medical Class II Updated 2019-07-24

Roche Diagnostics Corporation recalls The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. An

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, IN, KY
Lot/Code Info: Lot 368756
View official government recall

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