CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report

Roche Elecsys Anti-CCP Immunoassay recalled

Roche Diagnostics Operations is recalling Roche Elecsys Anti-CCP Immunoassay, distributed in 18 states. The recall was initiated on 16 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 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

Quantity recalled135 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2361-2019
FDA event ID: 83416
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 16 Jul 2019
FDA classified: 23 Aug 2019
Reported: 4 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

16 Jul 2019	Recall initiated by company
23 Aug 2019	Classified by FDA	+38 days
4 Sep 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

Where it was distributed

AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA

Arizona California Florida Iowa Illinois Kentucky Louisiana Massachusetts Michigan Missouri Montana New Jersey New York Pennsylvania Puerto Rico South Carolina Texas Virginia

Questions about this recall

Is Roche Elecsys Anti-CCP Immunoassay recalled?

Yes. Roche Diagnostics Operations recalled Roche Elecsys Anti-CCP Immunoassay on 16 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2361-2019.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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