FDA (Devices) recall action 64164
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Affected products have a labeled expiration date of one year too long.
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.
Bion Enterprises is recalling 201 units of IgM Conjugate because the labeled expiration date is one year too long.
Bion Enterprises is recalling 504 units of IgG FITC Conjugate because the labeled expiration date is one year too long.
Bion Enterprises Ltd is recalling 207 units of IgG Conjugate because the labeled expiration date is one year too long.