FDAFDA · Food and drugs·Recall number Z-0733-2024
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Published January 24, 2024 · Recall initiated: December 12, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Greiner Bio-One North America, Inc.
- Distributor
- US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
- Lot
- Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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