Device product
Kit BD Max CT/GC/TV; Catalog # 442970
Z-2331-2019
Product summary
- Event
- Event 83406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 913 units
- Official record key
device-enforcement:Z-2331-2019
Official wording
Reason: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Code information: Lot # 9080876; UDI (GTIN, DI+PI): (01)00382904429706 (17)200414(10)9080876(30)1; Exp: 4/14/2020 Lot #9092733; UDI (GTIN, DI+PI): (01)00382904429706 (17)200414(10)9092733(30)1; Exp: 4/14/2020 Lot #9092734; UDI (GTIN, DI+PI): (01)00382904429706 (17)200512(10)9092734(30)1; Exp: 5/12/2020 Lot #9106875; UDI (GTIN, DI+PI): (01)00382904429706 (17)200512(10)9106875(30)1; Exp: 5/12/2020
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.