Z-1519-2018 Class II Terminated
FDA device recall Z-1519-2018 was initiated by Roche Diagnostics Corporation on Jan 2, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 25, 2019). Affected quantity: 35,111.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Jan 2, 2018
- Termination Date
- Apr 25, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,111
Product Description
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."
Distribution Pattern
Nationwide Distribution
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1519-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026