Roche Diagnostics Corporation: Medical Device Recall in 2019 - (Recall #: Z-1979-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 3, 2019

Date Posted: July 24, 2019

Recall Number: Z-1979-2019

Event ID: 83095

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

Lot 368756

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated