Medical Device Recall: VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Greiner Bio-One North America, Inc. · May 14, 2024
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.
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.
States Affected
NATIONWIDE
Quantity Affected
1,008,000pcs (840 cartons)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2375-2024
Status: ongoing
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