Greiner Bio-One North America, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0818-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

Product Classification:

Class II

Date Initiated: November 25, 2019

Date Posted: January 29, 2020

Recall Number: Z-0818-2020

Event ID: 84536

Reason for Recall:

The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.

Status: Terminated

Product Quantity: 1,002,000 tubes

Code Information:

DI: 29120049204476, Lot number B190338E

Distribution Pattern:

Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA

Voluntary or Mandated:

Voluntary: Firm initiated