FDA recall Z-2362-2019

Roche Diagnostics Operations, Inc. · Class II · device

Product

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-07-16
Report date: 2019-09-04
Termination date: 2021-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2019