FDA (Devices) recall action 76659
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.
The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
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.
Tosoh Bioscience is recalling 64 boxes of AIA-PACK TgAb Control Set because the labels included instructions for a non-FDA approved methodology.
Tosoh Bioscience is recalling 15 boxes of AIA-PACK TPOAb Control Sets because the labels included instructions for a non-FDA approved methodology.