FDA recall Z-2375-2024

Greiner Bio-One North America, Inc. · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2024-05-14
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2375-2024