Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont,
FDA device recall Z-2761-2019 · posted 2019-09-27 · Terminated
Recall details
- Recalling firm
- Helena Laboratories, Corp.
- 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.
- 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.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- GFO
- Quantity affected
- 21 kits
- Distribution
- Distribution was made to Germany and Australia. There was no U.S. distribution.
- Date initiated
- 2017-12-07
- Date posted
- 2019-09-27
- Date terminated
- 2020-06-09
- Location
- Beaumont, TX
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