Bilirubin Total Gen — Class II medical device recall Z-1145-2019
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-1145-2019 |
|---|---|
| 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 | 05795320160, 05795338160, 05795346160, 05795397190, 05795419190, 05795648190 |
Product
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
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-1145-2019. 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.