Roche cobas 8000 modular analyzer series — Class II medical device recall Z-0754-2021

Ongoing recall by Roche Diagnostics Operations, Inc., reported 2021-01-06, distributed nationwide. Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated so

Recall number	`Z-0754-2021`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Roche Diagnostics Operations, Inc., Indianapolis, IN, United States
Recall initiated	2020-12-08
Classified	2020-12-30
Reported by FDA	2021-01-06
Distributed	Nationwide (US)
Quantity	1,050 units
Serial numbers	`1017-01`, `1017-04`, `1019-09`, `1020-01`, `1022-05`, `1029-09`, `1030-08`, `1030-09`, `1030-10`, `1034-09`, `1036-07`, `1138-03`, `1138-04`, `1140-09`, `1140-10`, `1142-01`, `1142-02`, `1142-04`, `1142-05`, `1142-06`, `1142-08`, `1142-09`, `1142-10`, `1143-01`, `1143-06` and 475 more
Model numbers	`08763662001`

Product

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

Reason for recall

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

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-0754-2021. 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.