Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2362-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

Product Classification:

Class II

Date Initiated: July 16, 2019

Date Posted: September 4, 2019

Recall Number: Z-2362-2019

Event ID: 83416

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.

Status: Terminated

Product Quantity: 550

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated