Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.
What to do
FDA enforcement status: Terminated
Brands named
UPCs
Recall history
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