Lower risk Medical device recall · FDA · Published January 26, 2024

Ortho-Clinical VITROS XT 7600 System Software Defect May Cause Erroneous Patient Results

Ortho-Clinical recalls VITROS XT 7600 Integrated System software versions 3.8.0 and 3.8.1 due to a defect that may cause QC results to be accepted incorrectly, potentially leading to erroneous patient test results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1233-2024Medical device Ortho-Clinical ›

Lower-risk recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS XT 7600 Integrated Systems with specific software versions because a defect can cause quality control results to be accepted incorrectly. This may lead to patient test results that are not accurate, which could affect medical decisions. Read more at govinfonow.com/recall/56247-ortho-clinical-vitros-xt-7600-system-software-defect-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/56247-ortho-clinical-vitros-xt-7600-system-software-defect-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1233-2024

Cite this page

“Ortho-Clinical VITROS XT 7600 System Software Defect May Cause Erroneous Patient Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56247-ortho-clinical-vitros-xt-7600-system-software-defect-may-cause. Based on FDA recall #Z-1233-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2024%22&limit=1).

Ortho-Clinical Diagnostics, Inc. voluntarily recalled VITROS XT 7600 Integrated Systems with catalog number 6844461 running software versions 3.8.0 or 3.8.1 due to a software defect that may cause erroneous patient results, the FDA said on Jan. 26, 2024.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS XT 7600 Integrated System
Catalog No.: 6844461
Software Versions: 3.8.0, 3.8.1
UDI-DI: 10758750031610
US Serial Numbers: J76000050 through J76000873
OUS Serial Numbers: J76000106 through J76001761

The hazard

A software defect causes Configurable Westgard Rules to not report as expected when a new control is defined. This may result in the acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12). Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk (2026-07-15), Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk (2026-07-15), and Roche cobas pro integrated solutions recall (2026-01-20).

How to tell if you have this one

Check if your VITROS XT 7600 Integrated System has software versions 3.8.0 or 3.8.1. The system's serial numbers and UDI-DI codes are listed in the recall notice for identification.

Brand
Ortho-Clinical
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

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.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-1229-2024	VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished); VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers: US: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222 J36001283 J36001330 J36001348 OUS: J36000148 J36001000 J36001495 J36000340 J36001012 J36001513 J36000348 J36001024 J36001515 J36000406 J36001026 J36001519 J36000407 J36001027 J36001528 J36000427 J36001051 J36001530 J36000446 J36001088 J36001535 J36000511 J36001108 J36001558 J36000517 J36001111 J36001570 J36000580 J36001112 J36001573 J36000612 J36001117 J36001575 J36000626 J36001154 J36001579 J36000688 J36001229 J36001581 J36000753 J36001237 J36001582 J36000861 J36001245 J36001583 J36000877 J36001246 J36001595 J36000920 J36001401 J36001600 J36000923 J36001403 J36001602 J36000929 J36001427 J36001608 J36000933 J36001451 J36001618 J36000941 J36001488 J36001632 J36000942 J36001489 J36001640	9 US; 66 OUS
Z-1230-2024	VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished); VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers: US: J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704 OUS: J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910	15 US; 43 OUS
Z-1231-2024	VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished); VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers: US: J56000116 J56003369 J56000317 J56003373 J56001292 J56003377 J56001523 J56003433 J56001629 J56003477 J56001885 J56003478 J56001886 J56003484 J56001910 J56003496 J56002041 J56003541 J56002159 J56003570 J56002198 J56003578 J56002199 J56003581 J56002201 J56003583 J56002249 J56003632 J56002301 J56003646 J56002308 J56003655 J56002461 J56003668 J56002463 J56003669 J56002466 J56003670 J56002474 J56003672 J56002477 J56003725 J56002500 J56003730 J56002591 J56003752 J56002603 J56003759 J56002607 J56003774 J56002608 J56003911 J56002615 J56004068 J56002698 J56004137 J56002703 J56004174 J56002704 J56004240 J56002722 J56004325 J56002769 J56004326 J56002895 J56004485 J56003035 J56004491 J56003045 J56004498 J56003076 J56004506 J56003113 J56004512 J56003199 J56004549 J56003220 J56004551 J56003287 J56004571 J56003299 J56004577 J56003317 J56004587 J56003330 J56004589 J56003334 J56004604 J56003342 J56004606 J56003356 OUS: J56000190 J56001929 J56000246 J56001944 J56000418 J56001979 J56000425 J56002028 J56000468 J56002064 J56000512 J56002085 J56000533 J56002099 J56000665 J56002116 J56000671 J56002218 J56000674 J56002258 J56000680 J56002300 J56000719 J56002410 J56000809 J56002460 J56000831 J56002518 J56000836 J56002615 J56000910 J56002625 J56000929 J56002637 J56000993 J56002784 J56000994 J56002821 J56001015 J56002862 J56001051 J56002913 J56001097 J56002926 J56001111 J56002929 J56001114 J56002966 J56001140 J56003061 J56001208 J56003162 J56001210 J56003179 J56001237 J56003260 J56001260 J56003285 J56001320 J56003401 J56001355 J56003451 J56001378 J56003464 J56001389 J56003508 J56001469 J56003523 J56001509 J56003538 J56001591 J56003919 J56001631 J56003951 J56001689 J56004078 J56001731 J56004082 J56001733 J56004308 J56001765 J56004309 J56001780 J56004346 J56001793 J56004355 J56001826 J56004414 J56001844 J56004415 J56001853 J56004531 J56001925 J56004695	91 US; 94 OUS
Z-1232-2024	VITROS XT 3400 Chemistry System, Catalog No. 6844458; VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031986 Serial Numbers: US: J34500140 J34500180 J34500257 J34500289 J34500319 J34500386 J34500422 J34500447 J34500473 J34500474 J34500510 J34500539 J34500547 J34500579 J34500588 J34500622 J34500656 J34500777 J34500818 J34500861 J34500887 J34500893 J34500896 J34500911 J34500931 OUS: J34500123 J34500128 J34500129 J34500130 J34500190 J34500261 J34500269 J34500271 J34500292 J34500301 J34500337 J34500356 J34500363 J34500515 J34500520 J34500536 J34500582 J34500609 J34500628 J34500658 J34500711 J34500793 J34500802 J34500940 J34500960 J34500962	25 US; 26 OUS
Z-1233-2024	VITROS XT 7600 Integrated System, Catalog No. 6844461; VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031610 Serial Numbers: US: J76000050 J76000878 J76001555 J76000108 J76000905 J76001558 J76000144 J76000909 J76001559 J76000148 J76000922 J76001565 J76000179 J76000930 J76001570 J76000192 J76000968 J76001577 J76000195 J76001106 J76001581 J76000199 J76001171 J76001583 J76000200 J76001172 J76001589 J76000206 J76001206 J76001592 J76000207 J76001207 J76001595 J76000208 J76001218 J76001596 J76000241 J76001230 J76001597 J76000298 J76001231 J76001599 J76000313 J76001232 J76001600 J76000317 J76001234 J76001611 J76000324 J76001235 J76001616 J76000333 J76001239 J76001617 J76000342 J76001260 J76001620 J76000352 J76001263 J76001638 J76000353 J76001270 J76001639 J76000420 J76001274 J76001643 J76000422 J76001292 J76001644 J76000456 J76001293 J76001647 J76000459 J76001294 J76001648 J76000460 J76001331 J76001650 J76000468 J76001340 J76001652 J76000495 J76001351 J76001659 J76000502 J76001357 J76001660 J76000524 J76001370 J76001666 J76000525 J76001376 J76001667 J76000537 J76001383 J76001668 J76000561 J76001384 J76001669 J76000609 J76001385 J76001671 J76000709 J76001392 J76001674 J76000743 J76001404 J76001675 J76000747 J76001406 J76001678 J76000783 J76001516 J76001679 J76000790 J76001517 J76001687 J76000803 J76001518 J76001692 J76000805 J76001519 J76001700 J76000806 J76001520 J76001703 J76000817 J76001535 J76001705 J76000862 J76001540 J76001711 J76000866 J76001549 J76001714 J76000868 J76001552 J76001748 J76000871 J76001553 J76001879 J76000873 OUS: J76000106 J76000976 J76000118 J76000983 J76000211 J76001001 J76000253 J76001027 J76000257 J76001035 J76000265 J76001070 J76000274 J76001074 J76000276 J76001095 J76000278 J76001111 J76000280 J76001121 J76000281 J76001130 J76000284 J76001141 J76000288 J76001142 J76000289 J76001144 J76000290 J76001152 J76000292 J76001155 J76000293 J76001159 J76000370 J76001174 J76000436 J76001183 J76000446 J76001189 J76000447 J76001272 J76000475 J76001273 J76000620 J76001285 J76000628 J76001309 J76000760 J76001314 J76000782 J76001328 J76000807 J76001368 J76000813 J76001377 J76000838 J76001378 J76000845 J76001379 J76000855 J76001396 J76000856 J76001399 J76000888 J76001407 J76000898 J76001408 J76000901 J76001452 J76000973 J76001457 J76001484 J76001547 J76001562 J76001563 J76001673 J76001761	142 US; 78 OUS

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your VITROS XT 7600 system's software version by checking the system settings or documentation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 47 days after the firm started it.

Jan 26, 2024Firm started the recall
Mar 1, 2024FDA classified it Class II
Mar 13, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/56247-ortho-clinical-vitros-xt-7600-system-software-defect-may-cause">Ortho-Clinical VITROS XT 7600 System Software Defect May Cause Erroneous Patient Results (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1233-2024 (January 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1233-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.