medical Class II Updated 2018-12-19

Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOST

Recalled Product

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 low to moderate heparin on coagulation in fresh whole blood.


Hazard / Issue

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

Issued by

FDA

Affected States: TX
Lot/Code Info: Lot Codes: 1-15-5701 Model/Catalog Number: 5701
View official government recall

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