Z-2362-2019Class II

Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

Name: Z-2362-2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-07-16
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-07-16 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 on 2019-07-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2362-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Posted: 2019-08-23
Terminated: 2021-04-30
Recalling firm: Roche Diagnostics GmbH
Product: Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Product code: NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
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.
FDA root cause: Under Investigation by firm
Action: Customers will be instructed to only use serum samples when testing with one of the affected lots numbers. Re-measure the sample if an implausible result occurs while using plasma samples, and a high Anti-CCP result does not match the patients clinical picture. To follow the work-around provided in the UMDC concerning pre-analytical sample handling for plasma samples. Perform maintenance according to the operator manual (e.g., Liquid Flow Cleaning [LFC]) to ensure proper functioning of the analyzer or module. Customers will be reminded that sample quality can be affected by fibrin clots and how this significantly impacts the Anti-CCP results. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. ***Updated 7/17/20*** An updated letter was sent out to customers on July 13, 2020. After further investigation, Roche has decided to remove human plasma as a sample type from the intended use and remove all claims associated with the plasma sample type. The change is applicable for all current and upcoming lots. Customer actions required: " Use the Elecsys Anti-CCP assay with serum samples only for all current and future Elecsys Anti-CCP lot numbers. " ALL customers, complete the response form included with the letter and return to the firm " If you cannot run serum samples in your laboratory, complete the Product Information section of the response form to obtain reagent credit or contact your Roche sales representative for further options. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. " Discard Urgent Medical Device Correction TP-00714 if you previously received it.
Quantity in commerce: 550
Distribution: AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2362-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2361-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23
Z-2362-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code NHX

K081338Class IIRoche Elecsys Anti-Ccp Immunoassay, Roche Elecsys Precicontrol Anti-CcpRoche Diagnostics / cleared 2008-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)