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FDAApril 20, 2016device

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of lo...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

What to do

FDA enforcement status: Terminated

Brands named

helena laboratorieshelena

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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