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Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicat
Recalled June 28, 2023 · FDA recall Z-1975-2023 · Helena Laboratories
Hazard
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. · FDA Class II
Units
32 units
Sold at
Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
Description
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.
Product
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Manufacturer(s)
Helena Laboratories, Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →