Reported May 29, 2019 · Terminated
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
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?
- Cobas¿ infinity
- central lab IT solution Material Number07154003001 Calculator/Data Processing Module, For Clinical Use
- Lot codes and dates
- Software versions 2.0 thorough 2.5
- Serial Numbers
811918137181385814658146981470814818148581527815288161881628816528165581662
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
This product could cause temporary or reversible health problems — stop using it.
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