FDA (Devices) recall action 79076
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 ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
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.
Randox Laboratories is recalling Immunoassay Premium Plus Controls because the ACTH component does not meet the stability claims in the product instructions.
Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.