PlainRecalls
FDA Devices Moderate Class II Ongoing

VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

Reported: July 24, 2024 Initiated: May 14, 2024 #Z-2375-2024

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.

Details

Units Affected
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.
Location
Monroe, NC

Frequently Asked Questions

What product was recalled?
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged. Recalled by Greiner Bio-One North America, Inc.. Units affected: 1,008,000pcs (840 cartons).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2375-2024.