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Roche Diagnostics Operations, Inc. recalls Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Recalled September 4, 2019 · FDA recall Z-2362-2019 · Roche Diagnostics Operations
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. · FDA Class II
Units
550
Sold at
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Description
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.
Product
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →