Manufacturer

Helena Laboratories, Corp.

11 recalls in our database name Helena Laboratories, Corp. as the manufacturing or recalling firm.

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2023-06-28

Of the 11 recalls from Helena Laboratories, Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

HighFDA (Devices)·Z-1975-2023·2023-06-28
Serrated Blade Applicator Kit packaging may contain wrong applicator size
Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.
Product
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1244-2022·2022-06-15
FDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.
Product
V8 Immunodisplacement Kit REF 1803
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1108-2021·2021-02-17
Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Clot Time Issues
Helena Laboratories is recalling Cascade Abrazo aPTT Test Cards due to intermittent potential for shorter than expected clot times.
Product
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0635-2021·2020-12-23
Helena Laboratories Recalls K-ACT Actalyke Clotting Test Tubes
Helena Laboratories is recalling K-ACT Actalyke Clotting Test Tubes due to complaints of cracked or split caps.
Product
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2020·2019-12-04
Helena Laboratories Recalls Platelet Aggregation Kits Due to Contamination
Helena Laboratories is recalling Platelet Aggregation Kits because the Collagen Reagent vials may contain particulate matter or microbial growth.
Product
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNO
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0537-2020·2019-12-04
Helena Laboratories Recalls Collagen Reagent Due to Potential Contamination
Helena Laboratories is recalling Collagen Reagent kits because vials may contain particulate matter or microbial growth.
Product
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
Category
Medical Device
Distribution
10 states
LowFDA (Devices)·Z-0297-2020·2019-11-13
Helena Laboratories Recalls SPIFE Alkaline Hemoglobin Kits Due to Incorrect Instructions
Helena Laboratories is recalling 899 SPIFE Alkaline Hemoglobin Kits because they contain incorrect instruction inserts referencing unavailable electrode parameters.
Product
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
Category
Medical Device
Distribution
22 states
ModerateFDA (Devices)·Z-0045-2020·2019-10-16
Helena Laboratories Recalls SPIFE ImmunoFix-6 Kits Due to Missing Control Wells
Helena Laboratories is recalling 24 SPIFE ImmunoFix-6 kits because the plates lack control wells in the patient 1 area.
Product
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2761-2019·2019-10-09
Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Export
Helena Laboratories is recalling 21 kits of Cascade Abrazo aPTT Test Cards, Model 5722, distributed to Germany and Australia, due to potential false negative results.
Product
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1950-2019·2019-07-17
Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.
Product
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-1949-2019·2019-07-17
Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits
Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.
Product
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Category
Medical Device
Distribution
34 states