FDA (Devices) recall action 75394
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.
Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum 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.
Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias in plasma samples compared to serum samples.
Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias when testing plasma samples instead of serum.