Reported Jul 8, 2020 · Terminated
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Ortho Clinical Diagnostics
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS 5600 Integrated System Software Versions 3.3.3
- and below Product Code6802413
- Unique Identifier10758750002740
- Lot codes and dates
- Affected Serial Number RangeJ56000114- J56001879
- Amount recalled
- 2617 units (U.S.=1272; OUS=1344)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
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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