Recall Z-1763-2017— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-03-01, terminated 2018-07-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx. Reason: "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.".
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-01
- Terminated
- 2018-07-03
- Firm location
- Indianapolis, IN, United States
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."
Data sourced from openFDA. This site is unofficial and independent of the FDA.