Z-2324-2019 Class II Terminated
FDA device recall Z-2324-2019 was initiated by Becton Dickinson & Co. on July 17, 2019 and is designated Class II. Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. The recall status is terminated (terminated May 13, 2020). Affected quantity: 447 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 17, 2019
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 447 units
Product Description
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
Reason for Recall
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
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
Code Information
Lot# 9085668; UDI (GTIN, DI+PI):(01)00382904428181 (17)201024(10)9085668(30)1; Exp:10/24/2020 Lot # 9106887; UDI (GTIN, DI+PI):(01)00382904428181 (17)201107(10)9106887(30)1; Exp: 11/7/2020