Helena Laboratories, Corp.

Code	Device name	Class	Specialty	Clearances	Most recent
OBZ	Alpha-1-Antitrypsin Kit, Qualitative Phenotype	Class II	Immunology	1	2022-10-13
GKA	Abnormal Hemoglobin Quantitation	Class II	Hematology	1	2022-04-19

Date	Severity	Status	Recall #	Product	Code	Reason
2023-05-02	Class II	Ongoing	Z-1975-2023	Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicat…	—	Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of misse…
2022-04-06	Class II	Ongoing	Z-1244-2022	V8 Immunodisplacement Kit REF 1803	—	Due to microbial growth causing interference with interpretation.
2021-01-05	Class II	Terminated	Z-1108-2021	Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the …	—	Intermittent potential for shorter than expected clot times.
2020-11-09	Class II	Ongoing	Z-0635-2021	K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI…	—	Due to complaints received associated with cracked/split test tube caps.

Date	K-number	Device	Code	Class	Specialty
2022-10-13	K213396	SPIFE A1AT kit	OBZ	Class II	Immunology
2022-04-19	K192931	V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control	GKA	Class II	Hematology

Clearance cadence by quarter