Reported Mar 13, 2024 · Ongoing
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- Lot codes and dates
- VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished
- UD-DI 10758750007110 Serial NumbersUS:
88 of 88 codes
J56000116J56003369J56000317J56003373J56001292J56003377J56001523J56003433J56001629J56003477J56001885J56003478J56001886J56003484J56001910J56003496J56002041J56003541J56002159J56003570J56002198J56003578J56002199J56003581J56002201J56003583J56002249J56003632J56002301J56003646J56002308J56003655J56002461J56003668J56002463J56003669J56002466J56003670J56002474J56003672J56002477J56003725J56002500J56003730J56002591J56003752J56002603J56003759J56002607J56003774J56002608J56003911J56002615J56004068J56002698J56004137J56002703J56004174J56002704J56004240
- J56003342 J56004606 J56003356 OUS
94 of 94 codes
J56000190J56001929J56000246J56001944J56000418J56001979J56000425J56002028J56000468J56002064J56000512J56002085J56000533J56002099J56000665J56002116J56000671J56002218J56000674J56002258J56000680J56002300J56000719J56002410J56000809J56002460J56000831J56002518J56000836J56002615J56000910J56002625J56000929J56002637J56000993J56002784J56000994J56002821J56001015J56002862J56001051J56002913J56001097J56002926J56001111J56002929J56001114J56002966J56001140J56003061J56001208J56003162J56001210J56003179J56001237J56003260J56001260J56003285J56001320J56003401
- Amount recalled
- 91 US; 94 OUS
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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