Greiner Bio-One North America, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0733-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

Product Classification:

Class II

Date Initiated: December 12, 2023

Date Posted: January 24, 2024

Recall Number: Z-0733-2024

Event ID: 93606

Reason for Recall:

Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.

Status: Ongoing

Product Quantity: 495,600 tubes

Code Information:

Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.

Distribution Pattern:

US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated