Recall Z-1108-2021— Helena Laboratories, Corp.
Class II · Terminated
Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2021-01-05, terminated 2024-11-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.. Reason: Intermittent potential for shorter than expected clot times..
- Recalling firm
- Helena Laboratories, Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-05
- Terminated
- 2024-11-19
- Firm location
- Beaumont, TX, United States
Product description
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Reason for recall
Intermittent potential for shorter than expected clot times.
Data sourced from openFDA. This site is unofficial and independent of the FDA.