FDAJuly 16, 2019device
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
05031656160
Recall history
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