Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
This recall has been terminated (originally issued September 27, 2019).
- 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
- Official Source
- View on FDA website ↗
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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