Device product
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Z-2321-2019
Product summary
- Event
- Event 83406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130 units
- Official record key
device-enforcement:Z-2321-2019
Official wording
Reason: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Code information: Lot # 9114645; UDI (GTIN, DI+PI): (01)00180002781029 (17)200719(10)9114645(30)1
Distribution pattern: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan
Derived failure modes
-
Unknown
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.