Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Published April 19, 2017 · Recall initiated: March 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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 (URF) 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Corporation
- Distributor
- Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
- Lot
- Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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