medical Class II Updated 2019-09-04

Roche Diagnostics Operations, Inc. recalls Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

Recalled Product

Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, FL, HI, IA, IL, IN, KY, LA, MA, MI, MO, MT, NJ, NY, OK, OR, PA, SC, TX, VA
Lot/Code Info: 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
View official government recall

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