FDA (Devices) recall action 83523
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.
Prolonged clotting times
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 364 ROTEM ex-tem kits because they may produce prolonged clotting times. The recall affects specific lots distributed in the US and internationally.
Instrumentation Laboratory is recalling 722 ROTEM ex-tem kits because they may produce prolonged clotting times. The recall affects units distributed in the US and internationally.
Instrumentation Laboratory Co. is recalling 44 ROTEM ex-tem kits (Lot 42255801) because they may produce prolonged clotting times.