The Tina-quant lgA Gen — Class II medical device recall Z-1979-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-07-24, distributed in AL, IN, KY. Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control
| Recall number | Z-1979-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2019-06-03 |
| Classified | 2019-07-16 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-08-28 |
| Distributed | AL, IN, KY |
| Quantity | 8 units |
| Lot numbers | 368756 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1979-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.