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Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/1
Recalled December 19, 2018 · FDA recall Z-0594-2019 · Helena Laboratories
Hazard
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected · FDA Class II
Units
12 Kits
Sold at
US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
Description
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
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.
Manufacturer(s)
Helena Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →