Class III — 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 III |
| Status | Ongoing |
| Reason | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users. |
| Product | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems |
| Quantity | 899 kits |
| Distribution | US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan |
| Initiated | 2018-02-27 |
| Classified | 2019-11-05 |
| Recall number | Z-0297-2020 |
| 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 III recall — Helena Laboratories, Corp. (Z-0297-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83925/
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