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Recall Observatory FDA recall evidence

Device 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,

Z-0537-2020

May 23, 2018

Class III

Product summary

Firm
Helena Laboratories, Corp.
Event
Event 83930
Status
Ongoing
Classification
Class III
Quantity
64 Aggregation Kits
Official record key
device-enforcement:Z-0537-2020

Official wording

Reason: 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.

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

Distribution pattern: US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial growth