Recall Z-1764-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
| Date | Mar 23, 2017 (initiated Mar 1, 2017) |
| Status | Terminated |
| 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 (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. |
| Root cause | Under Investigation by firm |
| Action | Roche initiated a recall on 03/01/2017, notices were issued via UPS to customers and instructed customers to do the following: Roche is developing software version 03-01 to resolve this issue, and a Roche Representative will be contacting you in the near future to schedule an update. Until this software update is available, the rack buffering option for the BRF and URF modules must be disabled. If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined below to disable rack buffering. If your facility does not have an authorized cobas 8100 automated work |
| Quantity | 45 |
| Distribution | Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.