Reported Nov 25, 2020 · Terminated
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be…
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-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments
- and software systems Catalog Number07154003001
- Lot codes and dates
- Software versions from cobas infinity version 3.00.00
- onwards Serial Numbers
82014822298202882227820668196781946821218202782194821208152882231819588224681983821188216581886820828225682257817818233182304820878227681465819598223582180821818223681945822758166282065822538181782000
- Amount recalled
- 40 licenses
Where it was sold
- Nationwide
Why it was recalled
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
This product could cause temporary or reversible health problems — stop using it.
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