Roche Albumin BCP Reagent Recalled for Calibration Failures and QC Imprecision
Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to test performance issues (calibration failures and QC imprecision) rather than direct physical harm, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Corporation is recalling 774 units of Albumin BCP reagent, catalog number 05975573190, lot number 35651401. This in vitro test is used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
The recall is due to the reagent lot exhibiting calibration failures, QC imprecision, and elevated QC recovery. These issues are attributed to an elevated pH level causing higher absorbance values.
The affected product was distributed nationwide in the states of Georgia, Illinois, Kentucky, Michigan, and Texas. Users of this product should stop using the affected lot and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 774
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number 05975573190 Lot Number 35651401
Distribution
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