FDA (Devices) recall action 64610
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Negative bias in patient samples for Vitamin D
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 ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.