Device 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)
Z-0536-2020
Product summary
- Event
- Event 83930
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 383 Collagen Kits
- Official record key
device-enforcement:Z-0536-2020
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 (Aggregation kit containing Collagen), Exp. 11/30/18 Kit Lot # 5-17-5368 (Aggregation Kit containing Collagen), Exp. 05/31/2019
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
particulate matter
-
Microbial contamination
microbial growth