SPIFE Alkaline Hemoglobin Kit — Class III medical device recall Z-0297-2020
Ongoing recall by Helena Laboratories, Corp., reported 2019-11-13, distributed in AZ, CT, FL, GA, IL, IN, KS, KY…. Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorre
| Recall number | Z-0297-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2018-02-27 |
| Classified | 2019-11-05 |
| Reported by FDA | 2019-11-13 |
| Distributed | AZ, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NJ, NY, OH, PA, SC, TX, VA, WA, WI |
| Countries outside the US | CO, TW |
| Quantity | 899 kits |
| Lot numbers | 1-18-551977, 10-18-551977, 11-18-551977, 12-18-551977, 13-18-551977, 2-18-551977, 2017, 2018, 3-18-551977, 4-18-551977, 5-18-551977, 6-18-551977, 62-17-551977, 63-17-551977, 64-17-551977, 65-17-551977, 66-17-551977, 67-17-551977, 68-17-551977, 69-17-551977, 7-18-551977, 70-17-551977, 71-17-551977, 72-17-551977, 8-18-551977, 9-18-551977 |
| Model numbers | 3415 |
Product
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0297-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.