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

Recall date

January 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1519-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

Nationwide Distribution

Why it was recalled

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."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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