Reported Feb 19, 2020 · Terminated
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
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 core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
- Lot codes and dates
- All cobas infinity laboratory solution software versions are affected.
- Amount recalled
- 26 accounts
Where it was sold
Why it was recalled
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
This product could cause temporary or reversible health problems — stop using it.
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