Cobas 8100 bi-directional reformatter — Class II medical device recall Z-1763-2017
Terminated recall by Roche Diagnostics Corporation, reported 2017-04-19, distributed in AL, AR, CA, IA, IL, IN, LA, MA…. "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-
| Recall number | Z-1763-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-03-01 |
| Classified | 2017-04-08 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2018-07-03 |
| Distributed | AL, AR, CA, IA, IL, IN, LA, MA, MI, MO, NE, NJ, OH, PA, SC, TX |
| Quantity | 45 units |
| Reason classes | software |
| Model numbers | 743995400 |
Product
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."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1763-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.