FDA-Device2019-09-04Class II
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Roche Diagnostics Operations, Inc.
Hazard
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.
Sold states
AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
Affected count
550
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2362-2019Don't want to check this manually?
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