Roche Diagnostics Corporation recalls Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum a…

Recall date

March 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1194-2019

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.