Device product
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Z-1975-2023
Product summary
- Event
- Event 92297
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-1975-2023
Official wording
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.
Code information: Lot # 3-22, UDI-DI: M5255526870
Distribution pattern: Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
Derived failure modes
-
Unknown
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.