Greiner Bio-One North America, Inc.: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

Hazard

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.

Details from the source

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: US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA. Quantity: 495,600 tubes Lot/code info: Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.

UPC codes

39120017575130, 29120017575133

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.