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 Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished
- UD-DI 10758750007110 Serial Numbers US
J56001885J56003484J56001886J56003541J56001910J56003570J56002308J56003583J56002461J56003646J56002474J56003669J56002608J56003670J56002698J56004068J56002704J56004137J56003342J56004174J56003356J56004491J56003377J56004506J56003433J56004549J56003477
- J56004551 J56003478 J56004577 OUS
J56000425J56002518J56000512J56002615J56000533J56002625J56000674J56002637J56000680J56002926J56000719J56002929J56000809J56003061J56000831J56003260J56000836J56003285J56001051J56003401J56001111J56003464J56001114J56003508J56001208J56003523J56001731J56003538J56001765J56004346J56001826J56004355J56001853J56004415J56002085J56004531J56002116J56004695
- Amount recalled
- 30 US: 38 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
Why it was recalled
A software defect affecting VITROS Systems running VITROS Software Versions 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ortho-Clinical Diagnostics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.