Recall Z-2362-2019— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-2362-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-16

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-07-16, terminated 2021-04-30. It names one FDA 510(k) clearance: K081338. Product: Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160. Reason: 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..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Terminated: 2021-04-30
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K081338 — ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCPRoche Diagnostics·cleared 2008-09-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.