FDA (Devices) recall action 83758
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.
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
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 Tina-quant sTfR assays due to updated claims regarding rheumatoid factor interference.
Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.