FDA Device recall Z-2362-2019
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 by Roche Diagnostics Operations, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2362-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-16 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | AZ, CA, FL, HI, IA, IL, IN, KY, LA, MA, MI, MO, MT, NJ, NY, OK, OR, PA, PR, SC, TX, VA |
Product
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Reason
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.
Identifiers
| code_info | Lot # 376808 Exp 08/31/2019 Lot # 389165 Exp 09/30/2019 Anti-CCP assay: Anti-CCP Elecsys cobas e 100 The affec…Lot # 376808 Exp 08/31/2019 Lot # 389165 Exp 09/30/2019 Anti-CCP assay: Anti-CCP Elecsys cobas e 100 The affected lots of Anti-CCP have been distributed 02/28/2019 through 07/01/2019. ***Updated 7/17/20*** Current (in-date) and future lots of both Catalog numbers are impacted. In-date lots: 443981, exp. 07/31/2020 457164, exp. 09/30/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2019%22
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