FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
- Recall number
- Z-2361-2019
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
- Status
- Terminated
- Initiated
- 2019-07-16
- Posted
- 2019-08-23
- Terminated
- 2021-04-30
- 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.
- 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
- 135 units
- Distribution
- AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
- Lot, serial or model codes
- Lot # 376648 Exp : 08/31/2019 Lot # 388800 Exp : 09/30/2019 Anti-CCP assay: Anti-CCP Elecsys E2G 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: 461913, exp 7/31/2020 467132, exp 9/30/2020
- 510(k) numbers
- ["K081338"]
- PMA numbers
- not on file
- Product code
- NHX
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28