FDA (Devices) recall action 65162
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
A rare variant of TSH, identified in a small cluster of patients, is not detected.
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 Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant is not detected.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.
Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.
Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.
Siemens Healthcare Diagnostics is recalling Dimension Vista System TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.
Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.