Reported Mar 13, 2024 · Ongoing
VITROS XT 3400 Chemistry System, Catalog No. 6844458
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 XT 3400 Chemistry SystemCatalog No. 6844458
- Lot codes and dates
- VITROS System Software Version 3.8.1
- UDI-DI 10758750031986 Serial Numbers USJ34500180 J34500289 J34500422 J34500473
- J34500622 J34500861 J34500887 OUSJ34500515 J34500609 J34500802 J34500940
- Amount recalled
- 7 US; 4 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.
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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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