# FDA recall Z-1979-2019

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2019-06-03.

## 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.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1979-2019
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-03
- **Report date:** 2019-07-24
- **Termination date:** 2020-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2019

## Citation

> AI Analytics. FDA recall Z-1979-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1979-2019. Source: US FDA. Licensed CC0.

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