FDA (Devices) recall action 95259
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.
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
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.
Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.
Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.