FDA Medical Device Recalls (openFDA)
Helena Laboratories, Corp.: Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Recall number
- Z-2761-2019
- Recalling firm
- Helena Laboratories, Corp.
- Product
- Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Status
- Terminated
- Initiated
- 2017-12-07
- Posted
- 2019-09-27
- Terminated
- 2020-06-09
- 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.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 21 kits
- Distribution
- Distribution was made to Germany and Australia. There was no U.S. distribution.
- Lot, serial or model codes
- Lot number 2-17-5722, Exp. 2018-09-30
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFO
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28