Recall Z-2761-2019— Helena Laboratories, Corp.
Class II · Terminated
Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2017-12-07, terminated 2020-06-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.. Reason: Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay..
- Recalling firm
- Helena Laboratories, Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-07
- Terminated
- 2020-06-09
- Firm location
- Beaumont, TX, United States
Product description
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reason for recall
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.