Lower riskMedical device recall · FDA · Published July 16, 2019
Roche Elecsys Anti-CCP Assay Recall: Performance Issues with Cobas Analyzers
Roche recalls specific lots of Elecsys Anti-CCP assay kits for performance issues with cobas e 411, e 170, and other analyzers. Affected lots distributed from Feb 2019 to July 2019.
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.
“Roche Elecsys Anti-CCP Assay Recall: Performance Issues with Cobas Analyzers.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67422-roche-elecsys-anti-ccp-assay-recall-performance-issues-with-cobas. Based on FDA recall #Z-2362-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2362-2019%22&limit=1).
The FDA announced on July 16, 2019, that Roche Diagnostics Operations, Inc. voluntarily recalled the Roche Elecsys Anti-CCP Immunoassay due to performance issues with certain lots. The agency issued recall number Z-2362-2019 for the device.
Distribution: AZ, CA, FL, HI, IA, IL, IN, KY, LA, MA, MI, MO, MT, NJ, NY, OK, OR, PA, PR, SC, TX, VA
Units affected: 550
The hazard
Performance issues with certain lots of the Anti-CCP assay on the cobas e 411 analyzer, MODULAR ANALYTICS E 170 module, and cobas e 601, 602, and 801 modules using plasma samples were reported. The record does not mention specific incidents or injuries.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), American Contract Systems Convenience Kit Recall (June 29, 2026), and Siemens Atellica CH RCRP Test May Give False High Results recall (Aug. 17, 2026).
How to tell if you have this one
Check the lot number on the assay kit: 376808 (exp. 08/31/2019), 389165 (exp. 09/30/2019), 443981 (exp. 07/31/2020), or 457164 (exp. 09/30/2020). The kits were distributed from February 28, 2019, through July 1, 2019.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
Recall number
Product, codes & lots
Quantity
Z-2361-2019
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190; 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
135 units
Z-2362-2019
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160; 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
550
Based on the official FDA remedy
What to do — step by step
Check Assay Lot Number
Look for lot numbers 376808, 389165, 443981, or 457164 on the assay kit.
Where it went and when
Where it was distributed
Distributed in 21 states and Puerto Rico.
Listed by the agency
Not listed
FDA distribution: “AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2362-2019 (July 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2362-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.