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Recall Observatory FDA recall evidence

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

May 02, 2023

Class II

Product summary

Firm
Helena Laboratories, Corp.
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

    reason.no_named_rule · v1.0.0

    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.