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Helena Laboratories, Corp.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Helena Laboratories, Corp. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-06-28FDA-DeviceClass IISerrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
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.
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