FDA-Device2019-08-28Class II
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Becton Dickinson & Co.
Hazard
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Sold states
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
Affected count
130 units
Manufactured in
7 Loveton Cir, N/A, Sparks, MD, United States
Products
Kit BD Max Check-Points CPO IVD EU; Catalog # 278102
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2019Don't want to check this manually?
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