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 customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. |
| Product | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL |
| Quantity | 65 kits |
| Distribution | Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea |
| Initiated | 2016-10-14 |
| Classified | 2019-08-30 |
| Terminated | 2023-10-12 |
| Recall number | Z-2434-2019 |
| 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-2434-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81383/
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