Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

FDA Recall Z-1519-2018 · Posted None

Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodeLDP
Date Initiated2018-01-02
Date Terminated2019-04-25
Product Quantity35,111

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 (Waldenstrm s macroglobulinemia), may cause unreliable results."

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110726ROCHE ACETAMINOPHEN ASSAYRoche Diagnostics · 2011-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑