FDA Device recall Z-0045-2020
SPIFE ImmunoFix-6 Kit, Cat
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of SPIFE ImmunoFix-6 Kit, Cat by Helena Laboratories, citing the plates do not have wells punched for the controls in the patient 1 area.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0045-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-21 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Helena Laboratories |
| Distribution | IN, KY, MA, OH, OR, TN, TX |
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
The plates do not have wells punched for the controls in the patient 1 area.
Identifiers
| code_info | Lot 35-17-552583, exp. date 4/30/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Helena Laboratories
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitr…
FDA Device · Class II · 2023-06-28 · Helena Laboratories - V8 Immunodisplacement Kit REF 1803
FDA Device · Class II · 2022-06-15 · Helena Laboratories - Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of th…
FDA Device · Class II · 2021-02-17 · Helena Laboratories - K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING…
FDA Device · Class II · 2020-12-23 · Helena Laboratories - Collagen Reagent, Cat
FDA Device · Class III · 2019-12-04 · Helena Laboratories
All Helena Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.