FDA Device recall Z-1764-2017
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx by Roche Diagnostics, citing 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) mo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1764-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-01 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | AL, AR, CA, IA, IL, IN, LA, MA, MI, MO, NE, NJ, OH, PA, SC, TX |
Product
Cobas 8100 uni-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 (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.
Identifiers
| code_info | Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: URF module: 07441657001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1764-2017%22
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