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

Ortho-Clinical VITROS 5600 System Software Defect May Cause Erroneous Patient Results

Ortho-Clinical recalls VITROS 5600 Integrated Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include regular and refurbished models with listed serial numbers.

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

🇺🇸 FDA recall #Z-1226-2024Medical deviceOrtho-Clinical ›
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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 5600 Integrated Systems with software version 3.8.1 because a defect can cause patient test results to be reported incorrectly. This affects specific models and serial numbers sold in the U.S. and other regions. Read more at govinfonow.com/recall/56241-ortho-clinical-vitros-5600-system-software-defect-may-cause-erroneous.

Source Summary by GovInfoNow · govinfonow.com/recall/56241-ortho-clinical-vitros-5600-system-software-defect-may-cause-erroneous · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1226-2024

Cite this page

“Ortho-Clinical VITROS 5600 System Software Defect May Cause Erroneous Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56241-ortho-clinical-vitros-5600-system-software-defect-may-cause-erroneous. Based on FDA recall #Z-1226-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1226-2024%22&limit=1).

The FDA announced on Jan. 26, 2024, that Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software defect that may cause erroneous patient results. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Ortho-Clinical
  • Product: VITROS 5600 Integrated System
  • Catalog Nos.: 6802413 (regular), 6802915 (refurbished)
  • Software Version: 3.8.1
  • Regular UDI-DI: 10758750002740
  • Refurbished UD-DI: 10758750007110
  • Serial Numbers (US): J56001885, J56003484, J56001886, J56003541, J56001910, J56003570, J56002308, J56003583, J56002461, J56003646, J56002474, J56003669, J56002608, J56003670, J56002698, J56004068, J56002704, J56004137, J56003342, J56004174, J56003356, J56004491, J56003377, J56004506, J56003433, J56004549, J56003477, J56004551, J56003478, J56004577
  • Serial Numbers (OUS): J56000425, J56002518, J56000512, J56002615, J56000533, J56002625, J56000674, J56002637, J56000680, J56002926, J56000719, J56002929, J56000809, J56003061, J56000831, J56003260, J56000836, J56003285, J56001051, J56003401, J56001111, J56003464, J56001114, J56003508, J56001208, J56003523, J56001731, J56003538, J56001765, J56004346, J56001826, J56004355, J56001853, J56004415, J56002085, J56004531, J56002116, J56004695

The hazard

A software defect in VITROS Systems running Software Version 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This 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 Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (2026-07-15), Roche cobas pro integrated solutions recall: Software defect causes incorrect lab results (2026-01-20), and Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (2026-07-15).

How to tell if you have this one

Check if your VITROS 5600 system has catalog numbers 6802413 (regular) or 6802915 (refurbished) and software version 3.8.1. Serial numbers listed in the recall notice include both U.S. and other region codes.

  • 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 - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
Recall numberProduct, codes & lotsQuantity
Z-1224-2024VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished); VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers US: J36001167 OUS: J36000427 J36001117 J36001558 J36000580 J36001154 J36001570 J36000626 J36001229 J36001573 J36000688 J36001427 J36001575 J36000877 J36001451 J36001579 J36000920 J36001488 J36001582 J36000929 J36001489 J36001583 J36000942 J36001495 J36001595 J36001012 J36001519 J36001602 J36001051 J36001528 J36001608 J36001108 J36001530 J36001632 J36001111 J36001535 J360016401 US; 36 OUS
Z-1225-2024VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished); VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US: J46000240 J46000898 J46001030 J46001293 OUS: J46000150 J46001041 J46000190 J46001042 J46000499 J46001186 J46000564 J46001187 J46000801 J46001210 J46000821 J46001217 J46000910 J46001289 J46000933 J46001639 J46001029 J460016454 US; 18 OUS
Z-1226-2024VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished); VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers US: J56001885 J56003484 J56001886 J56003541 J56001910 J56003570 J56002308 J56003583 J56002461 J56003646 J56002474 J56003669 J56002608 J56003670 J56002698 J56004068 J56002704 J56004137 J56003342 J56004174 J56003356 J56004491 J56003377 J56004506 J56003433 J56004549 J56003477 J56004551 J56003478 J56004577 OUS: J56000425 J56002518 J56000512 J56002615 J56000533 J56002625 J56000674 J56002637 J56000680 J56002926 J56000719 J56002929 J56000809 J56003061 J56000831 J56003260 J56000836 J56003285 J56001051 J56003401 J56001111 J56003464 J56001114 J56003508 J56001208 J56003523 J56001731 J56003538 J56001765 J56004346 J56001826 J56004355 J56001853 J56004415 J56002085 J56004531 J56002116 J5600469530 US: 38 OUS
Z-1227-2024VITROS XT 3400 Chemistry System, Catalog No. 6844458; VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J345009407 US; 4 OUS
Z-1228-2024VITROS XT 7600 Integrated System, Catalog No. 6844461; VITROS System Software Version 3.8.1 UDI-DI 10758750031610 Serial Numbers US: J76000199 J76001383 J76000207 J76001385 J76000353 J76001392 J76000456 J76001404 J76000459 J76001406 J76000460 J76001516 J76000468 J76001518 J76000495 J76001519 J76000502 J76001520 J76000561 J76001581 J76001207 J76001583 J76001230 J76001611 J76001231 J76001620 J76001232 J76001644 J76001235 J76001647 J76001239 J76001660 J76001260 J76001668 J76001263 J76001671 J76001270 J76001674 J76001274 J76001692 J76001331 J76001700 J76001351 J76001748 OUS: J76000118 J76001070 J76000253 J76001074 J76000265 J76001095 J76000274 J76001121 J76000281 J76001130 J76000370 J76001152 J76000447 J76001174 J76000475 J76001328 J76000620 J76001377 J76000855 J76001378 J76000856 J76001396 J76000898 J76001399 J76000901 J76001407 J76000973 J76001408 J76000976 J76001484 J76001001 J76001673 J76001027 J76001761 J7600103544 US; 35 OUS
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your VITROS system's software version; if it is 3.8.1, it may be affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 21 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Connecticut, Florida, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, West Virginia, Wisconsin.

Recall timeline

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

1. Firm started the recall: Jan 26, 202412. FDA classified it Class II: Mar 1, 202423. Published in FDA’s Enforcement Report: Mar 13, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1226-2024 (January 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1226-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA