Tina-quant IgM Gen — Class II medical device recall Z-1147-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-04-24, distributed nationwide. New endogenous interference claims have been established for the following assays used on the cobas c 311 anal
| Recall number | Z-1147-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2018-12-17 |
| Classified | 2019-04-13 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 5,292 analytical |
| Model numbers | 03507041190, 03507149190, 03507190190, 05220726190 |
Product
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
Reason for recall
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
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-1147-2019. 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.