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Recall Observatory FDA recall evidence

Device product

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

Z-2375-2024

May 14, 2024

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 94817
Status
Ongoing
Classification
Class II
Quantity
1,008,000pcs (840 cartons)
Official record key
device-enforcement:Z-2375-2024

Official wording

Reason: 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.

Code information: Item Number: 455071P; UDI Case label: 39120017573068; UDI Rack label: 29120017573061; Lot Number: B24013MV

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.