Reported Dec 23, 2020 · Terminated
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative…
Roche Diagnostics Operations, 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: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Tina-quant C-Reactive Protein Gen.3, Catalog
- number 05172373190 - Product Usagethe in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers
- Lot codes and dates
- CRPL3 - lot 42402301
- Amount recalled
- 699 units
Where it was sold
Why it was recalled
Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
This product could cause temporary or reversible health problems — stop using it.
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