medical Class III Updated 2019-12-04

Helena Laboratories, Corp. recalls Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platel

Recalled 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,


Hazard / Issue

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.

Issued by

FDA

Affected States: TX, WV, OH, TN, GA, NY, ME, MA, LA, AZ
Lot/Code Info: Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369
View official government recall

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