FDA Device recall Z-1519-2018
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test by Roche Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1519-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-02 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Reason
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."
Identifiers
| code_info | Lot codes: 11021500 7/31/2016 12361201 5/31/2017 11031700 9/30/2018 15247301 8/31/2017 11071400 1/31/2016 18…Lot codes: 11021500 7/31/2016 12361201 5/31/2017 11031700 9/30/2018 15247301 8/31/2017 11071400 1/31/2016 18036001 11/30/2017 11071600 8/10/2016 19329601 1/31/2018 11101500 1/21/2016 20511301 5/31/2018 11111600 4/30/2018 24076801 8/31/2018 60482201 2/29/2016 60852601 5/31/2016 61385701 9/30/2016 62032101 1/31/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1519-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.