FDA (Devices) recall action 83416
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.
Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.