Cobas 8000 Modular Series system — Class II medical device recall Z-0675-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-02-28, distributed in AL, AZ, CA, CO, CT, DE, FL, GA…. A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect
| Recall number | Z-0675-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-07-28 |
| Classified | 2018-02-21 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2020-06-10 |
| Distributed | AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, TN, TX, UT, VA, WA, WI |
| Quantity | 399 |
| Reason classes | software |
| Serial numbers | 1015-05, 1017-04, 1019-09, 1020-01, 1022-01, 1022-05, 1022-09, 1027-02, 1027-04, 1029-09, 1030-08, 1030-09, 1030-10, 1031-04, 1032-10, 1034-09, 1034-10, 1036-07, 1138-03, 1138-04, 1140-09, 1140-10, 1142-01, 1142-02, 1142-04 and 374 more |
Product
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Reason for recall
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
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-0675-2018. 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.