Reported May 2, 2018 · Terminated
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Roche Diagnostics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
- Lot codes and dates
- Lot codes
110215007/31/2016123612015/31/2017110317009/30/2018152473018/31/2017110714001/31/20161803600111/30/2017110716008/10/2016193296011/31/2018111015001/21/2016205113015/31/2018111116004/30/2018240768018/31/2018604822012/29/2016608526015/31/2016613857019/30/2016620321011/31/2017
- Lot codes
- Amount recalled
- 35,111
Where it was sold
- Nationwide
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."
This product could cause temporary or reversible health problems — stop using it.
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