The Recall Desk
HighFDA (Devices)·Z-2361-2019·Announced 2019-09-04

Roche Elecsys Anti-CCP Immunoassay Recalled Due to 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 135 units of the Roche Elecsys Anti-CCP Immunoassay (Catalog # 07251670190). The recall is 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, 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. An update to the recall notes that current and future lots of both catalog numbers are also impacted, including in-date lots 461913 and 467132.

Healthcare facilities and laboratories should stop using the affected lots and contact Roche Diagnostics for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
135

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 7/31/2020 467132
  • exp 9/30/2020

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 →

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