Device product
Kit BD Max MRSA XT; Catalog # 443461
Z-2334-2019
Product summary
- Event
- Event 83406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-2334-2019
Official wording
Reason: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Code information: Lot # 9106890; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200828(10)9106890(30)1; Exp :8/28/2020 Lot # 9106891; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200909(10)9106891(30)1; Exp :9/9/2020 Lot # 9114657; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200922(10)9114657(30)1; Exp : 9/22/2020
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.