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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device

Helena Laboratories, Corp.: Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.; Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.

Agency Publication Date: November 22, 2019
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Affected Products

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 DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369 (Aggregation kit containing Collagen), Exp. 11/30/18 Kit Lot # 5-17-5368 (Aggregation Kit containing Collagen), Exp. 05/31/2019

Lot Numbers:
5-17-5368
3-17-5369
5-17-5368
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,

Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369

Lot Numbers:
5-17-5368
3-17-5369

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83930
Status: Active
Manufacturer: Helena Laboratories, Corp.
Manufactured In: United States
Units Affected: 2 products (383 Collagen Kits; 64 Aggregation Kits)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.