FDA-Device2023-06-28Class II
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Helena Laboratories, Corp.
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.
Sold states
Distribution to US states of PA, NE, MI, FL, AR, NY, TX, and CA, and to Thailand.
Affected count
32 units
Manufactured in
1530 Lindbergh Dr, Beaumont, TX, United States
Products
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2023Don't want to check this manually?
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