Reported Feb 5, 2020 · Terminated
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material…
Roche Diagnostics Operations, Inc.
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 Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module
- For Clinical Use Material Number07154003001
- Lot codes and dates
- Cobas infinity software version 2.4.1 through 2.5.4
- Amount recalled
- 20
Where it was sold
Why it was recalled
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
This product could cause temporary or reversible health problems — stop using it.
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