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FDAMay 23, 2018device

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 a...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

helena laboratorieshelena

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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