Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2362-2019·Announced 2019-09-04

Roche Elecsys Anti-CCP Immunoassay Recalled for Performance Issues

Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text cites 'performance issues' without reporting any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 550 units of the Roche Elecsys Anti-CCP Immunoassay (Catalog # 05031656160). The recall was initiated due to performance issues observed with certain lots of the assay when used with plasma samples on the cobas e 411 analyzer, MODULAR ANALYTICS E 170 module, and cobas e 601, 602, and 801 modules.

The affected lots were distributed between February 28, 2019, and July 1, 2019. An update to the recall in July 2020 indicated that current and future lots of both catalog numbers are also impacted, specifically in-date lots 443981 (expiring 07/31/2020) and 457164 (expiring 09/30/2020). The product was distributed to facilities in Arizona, California, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, and Virginia.

Healthcare facilities and laboratories should stop using the affected lots of the Elecsys Anti-CCP Immunoassay and contact Roche Diagnostics for further instructions regarding the recall and potential replacement.

The recalled product

Product: Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: performance-issue
Affected units: 550

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

exp. 07/31/2020 457164
exp. 09/30/2020

Distribution

Distributed in 22 states:

Part of a larger recall action

This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Roche Diagnostics Operations, Inc.

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