Greiner Bio-One North America, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2485-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

Product Classification:

Class II

Date Initiated: August 13, 2021

Date Posted: October 6, 2021

Recall Number: Z-2485-2021

Event ID: 88511

Reason for Recall:

Blood collection tubes may experience a clotting issue.

Status: Terminated

Product Quantity: 962,400 tubes

Code Information:

Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.

Distribution Pattern:

Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated