Z-2761-2019 Class II Terminated
FDA device recall Z-2761-2019 was initiated by Helena Laboratories, Corp. on December 7, 2017 and is designated Class II. 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. The recall status is terminated (terminated June 9, 2020). Affected quantity: 21 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- December 7, 2017
- Termination Date
- June 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 kits
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.
Distribution Pattern
Distribution was made to Germany and Australia. There was no U.S. distribution.
Code Information
Lot number 2-17-5722, Exp. 2018-09-30