FDA-Device2024-07-24Class II
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Greiner Bio-One North America, Inc.
Hazard
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
Sold states
Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV and WY.
Affected count
1,008,000pcs (840 cartons)
Manufactured in
4238 Capital Dr, Monroe, NC, United States
Products
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2375-2024Don't want to check this manually?
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