Z-1763-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 1, 2017
- Termination Date
- July 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 Units
Product Description
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Reason for Recall
"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."
Distribution Pattern
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Code Information
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400