FDAMarch 18, 2019device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
05975573190
Recall history
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