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 | Ongoing |
| Reason | Due to microbial growth causing interference with interpretation. |
| Product | V8 Immunodisplacement Kit REF 1803 |
| Quantity | 51 kits |
| Distribution | U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam, |
| Initiated | 2022-04-06 |
| Classified | 2022-06-07 |
| Recall number | Z-1244-2022 |
| 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-1244-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90060/
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