FDA Device recall Z-1979-2019
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay
- FDA Device
- Class II
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of The Tina-quant lgA Gen.2 is an immunoturbidimetric assay by Roche Diagnostics, citing 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 rea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1979-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-03 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics |
| Distribution | AL, IN, KY |
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
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.
Identifiers
| code_info | Lot 368756 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1979-2019%22
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