FDA (Devices) recall action 66894
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.
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
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.
Instrumentation Laboratory is recalling 8,0319 kits of HemosIL Normal Control 1 UNASSAYED because the product lacks FDA 510(k) approval.
Instrumentation Laboratory is recalling 6,504 kits of HemosIL Low Abnormal Control 2 UNASSAYED because the product lacks FDA 510(k) approval.
Instrumentation Laboratory is recalling 84,561 kits of HemosIL High Abnormal Control 3 UNASSAYED because the product lacks FDA 510(k) approval.