Abbott recalls ARCHITECT i1000SR, i2000SR, and i2000 analyzers with software version 9.41 and earlier due to software issues that may cause inaccurate test results for cardiac, metabolic, and other analytes.
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
Abbott is recalling specific models of their ARCHITECT i1000SR, i2000SR, and i2000 analyzers that have software version 9.41 or earlier. These devices may produce inaccurate test results for cardiac, metabolic, and other analytes due to software issues. Users should check if their device is affected and contact Abbott for guidance. Read more at govinfonow.com/recall/61739-abbott-architect-i1000sr-i2000sr-i2000-software-issues-may-cause-inaccurate.
Source Summary by GovInfoNow · govinfonow.com/recall/61739-abbott-architect-i1000sr-i2000sr-i2000-software-issues-may-cause-inaccurate · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0271-2022
“Abbott ARCHITECT i1000SR/i2000SR/i2000 Software Issues May Cause Inaccurate Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61739-abbott-architect-i1000sr-i2000sr-i2000-software-issues-may-cause-inaccurate. Based on FDA recall #Z-0271-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0271-2022%22&limit=1).
The FDA is recalling Abbott Laboratories ARCHITECT i1000SR, ARCHITECT i2000SR, and ARCHITECT i2000 diagnostic analyzer systems.
The recall is voluntary and was initiated by the firm. No specific hazard details were provided in the source text.
Abbott Laboratories has 33 other recalls on record since 2012-05-14.
Check if your device has the model numbers ARCHITECT i1000SR, i2000SR, or i2000 with software version 9.41 or earlier. The recall includes specific serial numbers listed in the official notice.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0271-2022 | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89; Product Description/List Number/Serial Numbers: ARCHITECT i1000SR UDI: (01)00380740001537(21)I1SR12345(240)01L8601 List Number: 1L86 Serial Numbers: i1SR00101 i1SR00102 i1SR00103 i1SR00104 i1SR00105 i1SR00106 i1SR00107 i1SR00108 i1SR00109 i1SR00110 i1SR00111 i1SR00112 i1SR00113 i1SR00114 i1SR00115 i1SR00116 i1SR00117 i1SR00118 i1SR00119 i1SR00120 i1sr00121 i1SR00122 i1SR00124 i1SR00201 i1SR00202 i1SR00203 i1SR00204 i1SR00205 i1SR00206 i1SR00207 i1SR00208 i1SR00209 i1SR00210 i1SR00211 i1SR00212 i1SR00213 i1SR00214 i1SR00215 i1SR00216 i1SR00217 i1SR00218 i1SR00219 i1SR00220 i1SR00221 i1SR00222 i1SR00223 i1SR00224 i1SR00225 i1SR00226 i1SR00227 i1SR00228 i1SR00229 i1SR00230 i1SR00231 i1SR00232 i1SR00233 i1SR00234 i1SR00235 i1SR00236 i1SR00237 i1SR00238 i1SR00239 i1SR00240 i1SR00241 i1SR00242 i1SR01001 i1SR01002 i1SR01003 i1SR01004 i1SR01005 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i1SR03857 i1SR03858 i1SR03859 i1SR03860 i1SR03861 i1sr03862 i1SR03863 i1SR03864 i1SR03865 i1SR03866 i1SR03867 i1SR03868 i1SR03869 i1SR03870 i1SR03871 i1SR03872 i1SR03873 i1SR03874 i1SR03875 i1sr03876 i1SR03877 i1SR03878 i1SR03879 i1SR03880 i1SR03881 i1SR03882 i1SR03883 i1SR03884 i1SR03885 i1SR03886 i1SR03887 i1SR03888 i1SR03889 i1SR03890 i1SR03891 i1SR03892 i1SR03893 i1SR03894 i1SR03895 i1SR03896 i1SR03897 i1SR03898 i1SR03899 i1SR03900 i1SR03901 i1SR03902 i1SR03903 i1SR03904 i1SR03905 i1SR03906 i1SR03907 i1SR03908 i1SR03909 i1SR03910 i1SR03911 i1SR03912 i1SR03913 i1SR03914 i1SR03915 i1SR03916 i1SR03917 i1SR03918 i1SR03919 i1SR03920 i1SR03921 i1SR03922 i1SR03923 i1SR03924 i1SR03925 i1SR03926 i1SR03927 i1SR03928 i1SR03929 i1SR03930 i1SR03932 i1SR03933 i1SR03934 i1SR03935 i1SR03936 i1SR03937 i1SR03938 i1SR03939 i1SR03940 i1SR03941 i1SR03942 i1SR03943 i1SR03944 i1SR03945 i1SR03946 i1SR03947 i1SR03948 i1SR03949 i1SR03950 i1SR03951 i1SR03952 i1SR03953 i1SR03954 i1SR03955 i1SR03956 i1SR03957 i1SR03958 i1SR03959 i1SR03960 i1SR03961 i1SR03962 i1SR03963 i1SR03964 i1SR03965 i1SR03966 i1SR03967 i1SR03968 i1SR03969 i1SR03970 i1SR03971 i1SR03972 i1SR03973 i1SR03974 i1SR03975 i1SR03976 i1SR03977 i1SR03978 i1SR03979 i1SR03980 i1SR03981 i1SR03982 i1SR03983 i1SR03984 i1SR03985 i1SR03986 i1SR03987 i1SR03988 i1SR03989 i1SR03990 i1SR03991 i1SR03992 i1SR03993 i1SR03994 i1SR03995 i1SR03996 i1SR03997 i1SR03998 i1SR03999 i1SR04000 i1SR04001 i1SR04002 i1SR04003 i1SR04004 i1SR04005 i1SR04006 i1SR04007 i1SR04008 i1SR04009 i1SR04010 i1SR04011 i1SR04012 i1SR04013 i1SR04014 i1SR04015 i1SR04016 i1SR04017 i1SR04018 i1SR04019 i1SR04020 i1SR04021 i1SR04022 i1SR04023 i1SR04024 i1SR04025 i1SR04026 i1SR04027 i1SR04028 i1SR04029 i1SR04030 i1SR04031 i1SR04032 i1sr04033 i1SR04034 i1SR04035 i1SR04036 i1SR04037 i1SR04038 i1SR04039 i1SR04040 i1SR04041 i1SR04042 i1SR04043 i1SR04044 i1SR04045 i1SR04046 i1SR04047 i1SR04048 i1SR04049 i1SR04050 i1SR04051 i1SR04052 i1SR04053 i1SR04054 i1SR04055 i1SR04056 i1SR04057 i1SR04058 i1SR04059 i1SR04060 i1SR04061 i1SR04062 i1SR04063 i1SR04064 i1SR04065 i1SR04066 i1SR04067 i1SR04068 i1SR04069 i1SR04070 i1SR04071 i1SR04072 i1SR04073 i1SR04074 i1sr04075 i1SR04076 i1SR04077 i1SR04078 i1SR04079 i1SR04080 i1SR04081 i1SR04082 i1SR04083 i1SR04084 i1SR04085 i1sr04086 i1SR04087 i1sr04088 i1SR04089 i1SR04090 i1SR04091 i1SR04092 i1SR04093 i1SR04094 i1SR04095 i1SR04096 i1SR04097 i1SR04098 i1SR04099 i1SR04100 i1SR04101 i1SR04102 i1SR04103 i1SR04104 i1SR04105 i1SR04106 i1SR04107 i1SR04108 i1SR04109 i1SR04110 i1SR04111 i1SR04112 i1SR04113 i1SR04114 i1SR04115 i1SR04116 i1SR04117 i1SR04118 i1SR04119 i1SR04120 i1SR04121 i1SR04122 i1SR04123 i1SR04124 i1SR04125 i1SR04126 i1SR04127 i1SR04128 i1SR04129 i1SR04131 i1SR04132 i1SR04133 i1SR04134 i1SR04135 i1SR04136 i1SR04137 i1SR04138 i1SR04139 i1SR04140 i1SR04141 i1SR04142 i1SR04143 i1SR04144 i1SR04145 i1SR04146 i1SR04147 i1SR04148 i1SR04149 i1SR04150 i1SR04151 i1SR04152 i1SR04153 i1SR04154 i1SR04155 i1SR04156 i1SR04157 i1SR04158 i1SR04159 i1SR04160 i1SR04161 i1SR04162 i1SR04163 i1SR04164 i1SR04165 i1SR04166 i1SR04167 i1SR04168 i1SR04169 i1SR04170 i1SR04171 i1SR04172 i1SR04173 i1SR04174 i1SR04175 i1SR04176 i1SR04177 i1SR04178 i1SR04179 i1SR04180 i1SR04181 i1SR04182 i1SR04183 i1SR04184 i1SR04185 i1SR04186 i1SR04187 i1SR04188 i1SR04189 i1SR04190 i1SR04191 i1SR04192 i1SR04193 i1SR04194 i1SR04195 i1SR04196 i1SR04197 i1SR04198 i1SR04199 i1SR04200 i1SR04201 i1SR04202 i1SR04203 i1SR04204 i1SR04205 i1SR04206 i1SR04207 i1SR04208 i1SR04209 i1SR04210 i1SR04211 i1SR04212 i1SR04213 i1SR04214 i1SR04215 i1SR04216 i1SR04217 i1SR04218 i1SR04219 i1SR04220 i1SR04940 i1SR05042 i1SR05064 i1SR05927 i1SR07172 i1SR09993 i1SR1624 i1SR2007 i1SR2315 i1SR3038 i1SR50000 i1SR50001 i1SR50002 i1SR5 | 20,994 systems |
| Z-0272-2022 | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;; Product Description/List Number ARCHITECT c4000 Module List Number: 2P24 UDI: (01)00380740003746(21)c4123456(240)02P2401 Serial Numbers: C400000 C400010 C400011 C400012 C400013 c400014 c400015 C400016 C400017 C400018 C400019 C400020 C400023 C400024 C400025 C400026 C400027 C400030 C400031 C400032 C400034 C400035 C400036 C400038 C400039 C400040 C400041 C400042 C400043 C400045 C400046 C400047 C400049 C400050 C400051 C400053 C400054 C400055 C400056 C400057 C400058 C400060 C400061 C400062 C400063 C400064 C400065 c400066 C400067 C400068 C400069 C400070 C400071 C400072 C400073 C400074 C400075 C400077 C400078 C400079 C400080 C400081 C400083 C400084 C400085 C400086 C400087 C400089 C400090 C400091 C400092 C400093 C400095 C400096 C400098 C400099 C400100 C400101 C400102 C400104 C400105 C400106 C400107 C400108 C400109 C400112 C400114 C400115 C400116 C400117 C400118 C400119 C400120 C400121 C400122 C400123 C400124 C400125 C400127 C400129 C400132 C400133 C400134 C400135 C400136 C400137 c400139 C400140 C400141 C400142 C400143 C400144 C400145 C400146 C400147 C400148 C400149 C400150 C400151 C400152 C400153 C400154 C400155 C400156 C400157 C400158 C400159 C400160 C400161 C400162 C400163 C400164 C400165 C400166 C400167 C400168 C400169 C400170 C400171 C400172 C400173 C400174 C400175 C400176 C400177 C400178 C400179 C400182 C400183 C400184 C400185 C400186 C400187 C400188 C400189 C400190 C400191 C400192 C400195 C400196 C400197 C400199 C400200 C400201 C400202 C400203 C400204 C400205 C400206 C400207 C400209 C400210 C400211 C400212 C400213 C400214 C400215 C400217 C400218 C400220 C400222 C400223 C400224 C400227 c400228 C400229 C400230 C400231 C400232 C400234 C400235 C400236 C400237 C400238 C400239 C400240 C400241 C400242 C400243 C400244 C400245 C400246 C400247 C400248 C400250 C400251 C400252 C400253 C400254 C400256 C400258 C400259 C400260 C400261 C400262 C400263 C400264 C400266 C400268 C400269 C400270 C400271 C400273 C400274 C400275 C400276 C400277 C400278 c400279 C400280 C400281 C400282 C400283 C400284 C400285 C400287 C400288 C400289 C400290 C400291 C400292 C400293 C400294 C400295 C400296 C400297 C400298 C400299 C400300 C400301 C400302 C400303 C400304 C400305 C400306 C400307 C400309 C400310 C400312 C400313 C400315 C400316 C400317 C400318 C400319 C400320 C400321 C400322 C400324 C400325 C400326 C400327 C400328 C400329 C400331 C400332 C400333 C400334 C400335 C400337 C400338 C400340 C400341 C400342 C400344 C400345 C400347 C400348 C400349 C400350 C400351 C400352 C400354 C400355 C400356 C400357 C400358 C400359 C400362 C400363 C400364 C400365 C400366 C400367 C400368 C400369 C400370 C400371 C400373 C400374 C400375 C400376 C400377 C400378 C400379 C400380 C400381 C400382 C400383 C400384 C400385 C400386 C400387 C400388 C400389 C400390 C400391 C400392 C400393 C400394 C400395 C400397 C400398 C400399 C400400 C400402 C400403 C400404 C400405 C400406 C400407 C400408 C400409 C400410 C400411 C400412 C400413 C400414 C400415 C400416 c400417 C400418 C400419 C400420 C400422 C400423 C400424 C400425 C400426 C400427 C400428 C400429 C400430 C400431 C400432 C400433 C400434 C400435 C400436 C400437 C400439 C400440 c400442 C400443 C400444 C400445 C400446 C400447 C400448 C400449 C400450 C400451 C400453 C400454 C400455 C400456 C400457 C400459 C400460 C400461 C400463 C400464 C400465 C400466 C400467 C400468 C400469 C400470 C400471 C400472 C400473 C400474 C400475 C400476 C400477 C400478 C400479 C400480 C400481 C400482 C400483 C400484 C400485 C400486 C400487 C400488 C400489 c400490 C400491 C400492 C400493 c400494 C400495 C400496 C400497 C400498 C400499 C400500 C400501 C400502 C400503 C400504 C400505 C400508 C400509 C400510 C400511 C400512 C400513 C400514 C400515 C400516 C400518 c400519 C400520 C400521 C400522 C400523 C400524 C400525 C400526 C400527 C400528 C400529 C400530 C400531 C400532 C400533 C400534 C400535 C400536 C400537 C400538 C400539 C400540 c400541 C400542 C400543 C400544 C400545 C400546 C400547 C400548 C400549 c400550 C400551 C400552 C400554 c400555 C400556 C400557 C400558 C400559 C400560 C400561 C400562 C400563 C400564 C400565 C400566 C400567 C400568 C400569 C400570 C400571 C400572 C400573 C400574 C400575 C400576 C400577 C400578 C400579 C400580 C400581 C400582 C400583 C400584 C400585 C400586 C400587 C400588 C400589 C400590 C400591 C400593 C400594 C400595 C400596 C400597 C400598 C400599 C400600 C400601 C400602 C400603 C400604 C400605 C400606 C400607 C400608 c400609 C400610 C400611 C400612 C400614 C400616 C400617 C400618 C400619 C400620 C400621 C400622 C400623 C400624 C400625 C400626 C400627 C400629 C400630 C400631 C400632 C400633 C400634 C400635 C400636 C400637 C400638 C400639 C400640 C400641 C400642 C400643 C400645 C400646 C400647 C400648 C400649 C400650 C400651 C400652 C400653 C400654 C400655 C400656 C400657 C400658 C400659 C400660 C400661 C400662 C400663 c400664 C400665 C400666 C400667 C400668 C400669 C400670 c400671 c400672 C400673 C400675 C400676 C400677 C400678 C400679 C400680 C400681 C400682 C400683 C400684 C400685 C400686 C400687 C400688 C400689 C400690 C400691 C400692 C400693 C400694 C400695 C400696 C400697 C400699 c400700 C400701 c400702 C400703 C400704 C400705 C400706 C400707 C400708 C400709 C400710 C400711 C400712 C400713 C400714 C400715 C400716 C400717 C400718 C400719 C400720 C400721 C400722 C400723 C400724 C400725 C400726 C400727 C400728 C400729 C400730 C400731 C400732 C400733 C400734 C400735 C400736 C400737 C400739 C400740 C400741 C400742 C400743 C400744 C400745 C400746 C400747 C400748 C400749 C400750 C400751 C400752 C400753 C400754 C400755 C400756 C400757 C400758 C400759 C400760 C400761 C400762 C400764 C400765 C400766 C400767 C400768 C400769 C400770 C400771 C400772 C400773 C400775 C400776 C400777 C400778 C400779 C400780 C400781 C400782 C400784 C400785 C400786 C400787 C400789 C400790 C400791 C400792 C400793 C400794 c400795 C400796 C400797 C400798 C400799 C400800 C400801 C400802 C400803 C400804 C400805 C400806 C400807 C400809 C400810 C400811 C400812 C400813 c400814 C400815 C400816 C400817 C400818 C400819 C400820 C400821 C400822 C400823 C400824 C400825 c400826 C400827 C400828 C400829 C400830 C400831 C400832 C400834 C400835 C400836 c400837 C400838 C400839 C400840 C400841 C400842 C400843 C400844 c400845 C400846 C400847 C400848 c400849 c400850 C400851 C400852 C400853 C400854 C400855 C400856 C400857 C400858 C400859 C400860 C400861 C400862 C400863 C400864 C400866 C400867 C400869 C400870 C400871 C400872 C400873 C400874 C400875 C400876 C400877 C400879 C400880 C400881 C400882 C400883 C400884 C400885 C400886 C400887 C400888 C400889 C400890 C400891 C400892 C400893 C400895 C400897 C400898 C400899 C400900 C400901 C400902 C400903 C400904 C400905 C400906 C400908 C400909 C400910 C400911 C400912 C400913 C400914 C400915 C400916 c400917 C400919 C400920 C400921 C400922 C400923 C400925 C400926 C400927 C400928 C400929 C400930 C400931 C400932 c400933 C400934 C400935 C400936 C400937 C400938 C400939 C400940 C400941 C400943 C400944 C400945 C400946 C400947 C400948 C400949 C400951 C400952 C400953 C400954 C400955 C400956 C400957 C400958 C400959 C400960 C400961 C400962 C400963 C400964 C400965 C400966 C400967 C400968 C400969 C400970 C400971 C400972 C400973 C400974 C400975 C400976 C400977 C400978 C400979 C400980 C400981 C400982 C400983 C400984 C400985 C400986 C400987 C400988 C400989 C400991 C400992 C400993 C400994 C400995 C400996 C400997 C400998 C400999 C401000 C401001 C401002 C401003 C401004 C401005 C401006 C401007 C401008 C401009 C401010 C401011 C401012 C401013 C401014 C401016 C401017 c401018 C401019 C401020 C401021 C401022 C401023 C401025 C401026 C401027 C401028 C401029 C401030 C401031 C401032 C401033 C401036 C401037 C401038 C401039 C401041 C401042 C401043 C401044 C401045 C401046 C401047 c401048 C401049 C401050 C401051 C401052 C401053 C401054 C401055 C401056 C401057 C401058 C401059 C401060 C401061 C401062 C401063 C401064 C401065 C401066 C401067 C401069 C401070 C401071 C401072 C401073 c401074 C401075 C401076 C401077 C401078 c401079 C401080 C401081 C401082 C401083 C401084 C401085 C401086 C401087 C401088 C401089 C401090 C401091 C401092 C401093 C401094 C401095 C401097 C401098 C401099 C401100 C401101 C401102 C401103 C401104 C401105 C401106 C401107 c401108 c401109 C401110 C401112 C401113 C401114 C401115 C401116 C401117 C401118 C401119 C401120 C401121 C401124 C401125 C401126 C401127 C401128 C401129 C401130 C401131 C401132 C401133 C401134 C401135 C401137 C401138 C401139 C401140 C401141 C401142 C401143 C401144 C401145 C401146 C401147 C401148 C401149 C401150 C401151 C401152 C401153 C401154 C401155 C401156 c401157 C401158 C401159 c401160 C401161 C401162 C401163 C401164 C401165 C401166 C401167 c401168 C401169 C401170 C401171 C401172 C401173 C401174 C401175 C401176 C401177 C401178 C401179 C401180 C401181 C401182 c401183 C401185 c401186 C401187 C401188 C401189 C401190 C401191 c401192 C401193 C401194 C401195 C401196 C401197 C401198 C401199 C401200 c401201 C401202 C401203 C401204 C401205 c401206 C401207 C401208 C401209 C401210 C401211 C401212 C401213 C401214 C401215 C401216 C401217 C401218 C401219 C401220 C401221 C401222 C401223 C401224 C401225 C401226 C401227 C401228 C401229 C401230 C401231 C401232 C401233 C401234 C401235 C401236 C401237 C401238 C401239 C401240 C401241 C401242 C401243 C401244 C401245 C401246 C401247 C401248 C401249 C401250 C401251 C401252 C401253 C401254 C401255 C401256 C401257 C401258 C401259 C401260 C401261 c401262 C401263 C401264 C401265 C401266 C401267 C401268 C401269 C401270 C401271 C401272 C401273 C401274 C401275 C401276 C401277 C401278 C401279 C401280 C401281 C401282 C401283 C401284 C401285 C401286 C401287 C401288 C401289 C401290 c401291 C401292 C401293 C401294 C401295 C401296 C401297 C401298 C401299 C401300 C401301 C401302 C401303 C401304 C401305 C401306 C401307 C401308 C401309 C401310 C401311 C401312 C401313 C401314 C401315 C401316 C401317 C401318 C401319 C401320 C401321 C401322 C401323 C401324 C401325 C401326 C401327 C401328 C401329 C401330 C401331 C401332 C401333 C401334 C401335 C401336 C401337 C401338 C401339 C401340 C401341 C401342 C401343 C401344 C401345 C401347 C401348 C401349 C401351 C401352 C401353 C401354 C401355 C401356 C401357 C401358 C401359 C401360 C401361 C401362 C401363 C401364 C401365 C401366 C401367 C401368 C401369 C401370 C401371 C401372 C401373 C401375 C401376 C401377 C401378 C401379 C401380 C401381 C401382 C401383 C401384 C401385 C401386 C401387 C401388 C401389 C401390 C401391 C401392 C401393 C401394 C401395 C401396 C401397 C401398 C401399 C401400 C401401 C401402 C401403 C401404 C401405 C401406 C401407 C401408 C401409 C401411 C401412 C401413 C401414 C401415 C401416 C401417 C401418 C401419 C401420 C401421 C401422 C401423 C401424 C401425 C401426 C401428 C401429 C401430 C401431 C401432 C401433 C401434 C401435 C401436 C401437 C401438 C401439 C401440 C401441 C401442 c401443 C401444 C401446 C401447 C401448 C401449 C401450 C401451 C401452 C401453 C401454 C401455 C401456 C401457 C401458 C401459 C401460 C401461 C401462 C401463 C401464 C401465 C401466 C401467 C401468 c401469 C401470 C401471 C401472 C401473 C401474 C401475 C401476 C401477 C401478 C401479 C401480 C401481 C401482 C401483 C401484 C401485 C401486 C401487 C401488 C401489 C401490 C401491 C401492 C401493 C401494 C401495 C401496 C401498 C401499 C401500 C401502 C401503 C401504 C401505 C401506 C401507 C401508 C401509 C401510 C401512 C401513 C401514 c401515 C401516 C401517 C401518 C401519 C401520 C401521 C401522 C401523 C401524 C401525 C401526 C401527 C401528 C401529 C401530 C401531 C401532 C401533 C401534 C401535 C401536 C401537 C401538 C401539 C401540 C401541 c401542 C401543 C401544 C401545 C401546 C401547 C401548 C401549 C401550 C401551 C401552 C401553 C401554 C401555 C401556 C401557 C401558 C401559 C401560 C401561 C401562 C401563 C401564 C401565 C401566 C401567 C401568 C401569 C401570 C401571 C401572 C401573 C401574 C401575 C401576 C401577 C401579 C401580 C401581 C401582 C401583 C401584 C401585 C401586 C401587 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C461114 C461115 C461117 c461118 c461119 C461120 C461121 C461122 C461123 C461124 C461125 C461126 C461127 C461128 C461129 C461130 C461131 C461132 C461133 c461134 C461135 C461136 C461137 C461138 C461139 C461140 C461141 C461142 c461143 C461144 C461145 C461146 C461147 C461148 C461149 C461150 C461151 C461152 C461153 c461154 C461155 C461156 C461159 C461160 C461161 c461162 C461163 c461164 C461165 C461166 C461167 C461168 C461169 C461170 C461171 C461172 C461173 C461174 C461175 C461176 C461177 c461178 c461179 C461180 C461181 C461182 C461183 C461184 C461185 C461186 C461187 C461188 C461189 C461190 C461191 C461192 C461193 c461194 C461195 C461196 C461197 C461198 C461199 C461200 C461202 C461204 C461205 C461206 C461207 C461208 C461209 C461210 C461212 C461213 | 7,535 systems |
Verify your device's software version by checking the device settings or documentation. If it is 9.41 or earlier, it is affected.
Reach out to Abbott Laboratories directly for instructions on how to update the software or replace the device if necessary.
Where it was distributed
Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: AFGHANISTAN…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
Dates from the agency record only; steps without a date are left out.
Check your device's serial number against the list of affected serial numbers provided in the official recall notice.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.