VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
FDA Recall #Z-2375-2024 — Class II — May 14, 2024
Product Description
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Reason for Recall
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.
Recalling Firm
Greiner Bio-One North America, Inc. — Monroe, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,008,000pcs (840 cartons)
Distribution
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.
Code Information
Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated