Recall archive / FDA device enforcement
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Appli... — FDA record Z-1975-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
- Reason
- 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 to incorrect or no result, or delay in result.
- Classification
- Class II
- Recalling firm
- Helena Laboratories, Corp.
- Quantity
- 32 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1975-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 3-22, UDI-DI: M5255526870 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 28, 2023
- Recall initiation date
- May 2, 2023
- Center classification date
- Jun 16, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.