FDA (Devices) recall action 78832
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.
Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
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.
Hologic is recalling 165 Rapid for the TLiIQ System kits because they were manufactured with a new material before FDA approval.
Hologic is recalling Rapid for the TLiIQ System cassettes because they were manufactured with material from a new supplier before FDA approval of the change.