Reported Dec 26, 2018 · Terminated
VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and…
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, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
- Lot codes and dates
- 1) Product Code 6802413 UDI 10758750002740; Serial Numbers J56000024 J56003358 2) Product Code 6802915 (Refurbished)
- UDI 10758750007110 Serial Numbers
560004275600075056001012560015355600115256001641560003275600058556001437560007865600025556001235560007925600106256000308560011845600031556000458560015705600082556000661560002615600055956000818560007475600113956000317560005135600075556000883560013345600144556001141560007565600082456000718560010215600033956000741560007275600113156001558560015305600108956001264560006465600065556001027560011285600079656000890560009285600135956001851560005335600111156001689
- Amount recalled
- 2413
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
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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