Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applica…

Recall date

May 2, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1975-2023

FDA classification

Class II

Brand / firm

Helena Laboratories, Corp.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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