Drug recall
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30…
FDA recall event 92297 · Class II · Helena Laboratories, Corp.
Key facts
| Event ID | 92297 |
|---|---|
| Recall numbers | Z-1975-2023 |
| Recalling firm | Helena Laboratories, Corp. |
| Product type | Devices |
| Products | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading… |
| Initiation date | May 2, 2023 |
| Report date | Jun 28, 2023 |
| City | Beaumont |
| State | TX |
| Country | United States |
| FEI number | 1618982 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: