Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 — Class II medical device recall Z-2362-2019
Terminated recall by Roche Diagnostics Operations, Inc., reported 2019-09-04, distributed in AZ, CA, FL, HI, IA, IL, IN, KY…. Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYT
| Recall number | Z-2362-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-07-16 |
| Classified | 2019-08-23 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2021-04-30 |
| Distributed | AZ, CA, FL, HI, IA, IL, IN, KY, LA, MA, MI, MO, MT, NJ, NY, OK, OR, PA, PR, SC, TX, VA |
| Quantity | 550 |
| Reason classes | potency |
| Lot numbers | 376808, 389165, 443981, 457164 |
| Model numbers | 05031656160 |
| Expiration dates | 2019-08-31, 2019-09-30, 2020-07-31, 2020-09-30 |
Product
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Reason for recall
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
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-2362-2019. 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.