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FDAJune 3, 2019device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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