FDAFebruary 4, 2019device

Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

07154003001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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