Class II — Helena Laboratories, Inc.
| 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 | Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected. |
| Product | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY |
| Quantity | 27 kits |
| Distribution | US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England |
| Initiated | 2017-02-24 |
| Classified | 2018-12-06 |
| Terminated | 2023-10-20 |
| Recall number | Z-0561-2019 |
| 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, Inc. (Z-0561-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81378/
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