Roche Diagnostics Corporation recalls Albumin BCP Product Usage: ALBP is an in vitro test use
Recalled 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.
Hazard / Issue
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Issued by
FDA
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