Helena Laboratories, Corp. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade ApplicatClass IIMay 2, 2023Packaging for a serrated blade applicator kit (12 Sample) ma	Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample).	Class IIDevices	May 2, 2023
V8 Immunodisplacement Kit REF 1803Class IIApr 6, 2022Due to microbial growth causing interference with interpreta	Due to microbial growth causing interference with interpretation.	Class IIDevices	Apr 6, 2022
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the Class IIJan 5, 2021Intermittent potential for shorter than expected clot times.	Intermittent potential for shorter than expected clot times.	Class IIDevices	Jan 5, 2021