Device product
Kit BD Max Enteric Viral Panel EU Catalog # 443985
Z-2339-2019
Product summary
- Event
- Event 83406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 469 units
- Official record key
device-enforcement:Z-2339-2019
Official wording
Reason: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Code information: Lot # 9085674; UDI (GTIN, DI+PI): (01)00382904439859 (17)201101(10)9085674(30)1; Exp: 11/1/2020 Lot # 9107980; UDI (GTIN, DI+PI): (01)00382904439859 (17)201107(10)9107980(30)1; Exp: 11/7/2020
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.