Recall Z-0594-2019— Helena Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Helena Laboratories, Inc., initiated 2016-04-20, terminated 2024-02-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected.
- Recalling firm
- Helena Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-20
- Terminated
- 2024-02-15
- Firm location
- Beaumont, TX, United States
Product description
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.
Reason for recall
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Data sourced from openFDA. This site is unofficial and independent of the FDA.