Z-0733-2024 Class II Ongoing

Recalled by Greiner Bio-One North America, Inc. — Monroe, NC

Recall Details

Product Type
Devices
Report Date
January 24, 2024
Initiation Date
December 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
495,600 tubes

Product Description

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

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.

Distribution Pattern

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

Code Information

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