FDAJanuary 2, 2018device
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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."
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
0325537916020767174160
Recall history
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