Reported Apr 24, 2019 · Terminated
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum…
Roche Diagnostics Corporation
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 Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Albumin BCP Product UsageALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems
- Lot codes and dates
- Catalog Number 05975573190 Lot Number 35651401
- Amount recalled
- 774
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
Why it was recalled
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
This product could cause temporary or reversible health problems — stop using it.
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