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Roche Diagnostics Corporation recalls Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human ser
Recalled April 24, 2019 · FDA recall Z-1194-2019 · Roche Diagnostics
Hazard
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. · FDA Class II
Units
774
Sold at
US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.
Description
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
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(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →