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
Product summary
- 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
particulate matter
-
Microbial contamination
microbial growth