SPIFE ImmunoFix-6 Kit — Class II medical device recall Z-0045-2020
Terminated recall by Helena Laboratories, Corp., reported 2019-10-16, distributed in IN, KY, MA, OH, OR, TN, TX. The plates do not have wells punched for the controls in the patient 1 area.
| Recall number | Z-0045-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2017-07-21 |
| Classified | 2019-10-04 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-06-19 |
| Distributed | IN, KY, MA, OH, OR, TN, TX |
| Countries outside the US | CL |
| Quantity | 24 kits |
| Lot numbers | 35-17-552583 |
| Model numbers | 3401, 3401T |
| Expiration dates | 2018-04-30 |
Product
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reason for recall
The plates do not have wells punched for the controls in the patient 1 area.
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-0045-2020. 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.