Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Company
- Helena Laboratories, Corp.
- Recall Initiated
- December 7, 2017
- Posted
- September 27, 2019
- Terminated
- June 9, 2020
- Recall Number
- Z-2761-2019
- Quantity
- 21 kits
- Firm Location
- 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
Distribution was made to Germany and Australia. There was no U.S. distribution.
Lot / Code Info
Lot number 2-17-5722, Exp. 2018-09-30
Root Cause
Unknown/Undetermined by firm
Action Taken
The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot.
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