Home / Recalls / Helena Laboratories, Corp. / Z-1975-2023

Z-1975-2023 Class II Ongoing

Recalled by Helena Laboratories, Corp. — Beaumont, TX

FDA device recall Z-1975-2023 was initiated by Helena Laboratories, Corp. on May 2, 2023 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 32 units.

Recall Details

Product Type
Devices
Report Date
June 28, 2023
Initiation Date
May 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units

Product Description

Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

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 to incorrect or no result, or delay in result.

Distribution Pattern

Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.

Code Information

Lot # 3-22, UDI-DI: M5255526870

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FDA data resources