Roche Acetaminophen assay 03255379160-HAcetaminophen — Class II medical device recall Z-1519-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-05-02, distributed nationwide. The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS an
| Recall number | Z-1519-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2018-01-02 |
| Classified | 2018-04-25 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-04-25 |
| Distributed | Nationwide (US) |
| Quantity | 35,111 |
| Reason classes | potency |
| Lot numbers | 11021500, 11031700, 11071400, 11071600, 11101500, 11111600, 12361201, 15247301, 18036001, 19329601, 20511301, 24076801, 60482201, 60852601, 61385701, 62032101 |
Product
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Reason for recall
The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."
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-1519-2018. 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.