Roche Diagnostics Corporation recalls The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form…

Recall date

June 3, 2019

Source

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

Recall number

Z-1979-2019

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

The products were distributed to the following US states: AL, IN, and KY.

Why it was recalled

Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.

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

What was recalled

The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.