Recall Z-0561-2019— Helena Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Helena Laboratories, Inc., initiated 2017-02-24, terminated 2023-10-20. 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. Reason: Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected..
- Recalling firm
- Helena Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-24
- Terminated
- 2023-10-20
- 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
Reason for recall
Due to some cards in this lot reported to have experienced variations in results, (verified by 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.