FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corporation: Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
- Recall number
- Z-1519-2018
- Recalling firm
- Roche Diagnostics Corporation
- Product
- Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
- Status
- Terminated
- Initiated
- 2018-01-02
- Posted
- not on file
- Terminated
- 2019-04-25
- 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 (Waldenstrm s macroglobulinemia), may cause unreliable results."
- Root cause
- Error in labeling
- Action
- On January 2, 2018 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers with notification to the issue and information regarding the updated method sheets and that they were available for use. The COBAS INTEGRA 400 plus/800/800 CTS was updated from affected method sheet version 3.0 to 4.0. The MODULAR ANALYTICS P was updated from affected method sheet version 4.0 to 5.0 No product return is required. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
- Quantity
- 35,111
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K110726"]
- PMA numbers
- not on file
- Product code
- LDP
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28