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

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.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.