Class II — Helena Laboratories, Corp.
| Recalling firm | HELENA LABORATORIES, CORP. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX. |
| Quantity | 21 kits |
| Distribution | Distribution was made to Germany and Australia. There was no U.S. distribution. |
| Initiated | 2017-12-07 |
| Classified | 2019-09-30 |
| Terminated | 2020-06-09 |
| Recall number | Z-2761-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Helena Laboratories, Corp. (Z-2761-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83629/
Alerts for HELENA LABORATORIES, CORP.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.