Helena Laboratories recalls

Helena Laboratories has 16 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 28 Jun 2023. 8 are still ongoing.

Total recalls16since 2018

Last 12 months0reported

Class I00% of total

Ongoing8latest 28 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 12 75%Class III 4 25%

Why helena laboratories is recalled

Product types

By year

202316%
202216%
202116%
202016%
2019850%
2018425%

Ongoing helena laboratories recalls

8 active

Reported	Class	Recall	Company	Reason	Where
28 Jun 2023Device	CLASS II	Serrated Blade Applicator Kit (12 Sample) recalled	Helena Laboratories	Packaging Defects	8 states
15 Jun 2022Device	CLASS II	V8 Immunodisplacement Kit recalled by Helena Laboratories	Helena Laboratories	Other	4 states
23 Dec 2020Device	CLASS II	K-act Actalyke Clotting Test Tubes that are used recalled	Helena Laboratories	Device Malfunction	Nationwide
4 Dec 2019Device	CLASS III	Collagen Reagent recalled by Helena Laboratories	Helena Laboratories	Particulate Matter	10 states
4 Dec 2019Device	CLASS III	Platelet Aggregation Kit recalled by Helena Laboratories	Helena Laboratories	Particulate Matter	10 states
13 Nov 2019Device	CLASS III	Spife Alkaline Hemoglobin Kit recalled by Helena Laboratories	Helena Laboratories	Other	22 states

All helena laboratories recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
28 Jun 2023Device	CLASS II	Serrated Blade Applicator Kit (12 Sample) recalled	Helena Laboratories	Packaging Defects	8 states
15 Jun 2022Device	CLASS II	V8 Immunodisplacement Kit recalled by Helena Laboratories	Helena Laboratories	Other	4 states
17 Feb 2021Device	CLASS II	Cascade Abrazo aPTT Test Card recalled by Helena Laboratories	Helena Laboratories	Other	Nationwide
23 Dec 2020Device	CLASS II	K-act Actalyke Clotting Test Tubes that are used recalled	Helena Laboratories	Device Malfunction	Nationwide
4 Dec 2019Device	CLASS III	Collagen Reagent recalled by Helena Laboratories	Helena Laboratories	Particulate Matter	10 states
4 Dec 2019Device	CLASS III	Platelet Aggregation Kit recalled by Helena Laboratories	Helena Laboratories	Particulate Matter	10 states
13 Nov 2019Device	CLASS III	Spife Alkaline Hemoglobin Kit recalled by Helena Laboratories	Helena Laboratories	Other	22 states
16 Oct 2019Device	CLASS II	Spife ImmunoFix-6 Kit recalled by Helena Laboratories	Helena Laboratories	Other	7 states
9 Oct 2019Device	CLASS II	Cascade Abrazo aPTT Test Card recalled by Helena Laboratories	Helena Laboratories	Potency & Assay	TX
11 Sep 2019Device	CLASS II	Titan Gel Serum Protein Control: SPE Control recalled	Helena Laboratories	Potency & Assay	10 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.