FDA-Device2018-12-19Class II
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.
Helena Laboratories, Inc.
Hazard
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Sold states
US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
Affected count
12 Kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2019Don't want to check this manually?
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