FDA recall Z-1975-2023

Helena Laboratories, Corp. · Class II · 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

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

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

Key facts

Status: Ongoing
Initiation date: 2023-05-02
Report date: 2023-06-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2023