Z-2321-2019 Class II Terminated
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
- 130 units
Product Description
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
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 # 9114645; UDI (GTIN, DI+PI): (01)00180002781029 (17)200719(10)9114645(30)1