Recall Z-1519-2018 ยท LDP Colorimetry, Acetaminophen
Roche Diagnostics Corporation
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
| Date | Jan 2, 2018 |
| Status | Terminated |
| 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 U |
| Quantity | 35,111 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110726 | ROCHE ACETAMINOPHEN ASSAY Roche Diagnostics, Dec 23, 2011 |