FDAMarch 21, 2017device
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric ana...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
045472410010589942700104945794001
Recall history
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