FDA-Device2024-01-24Class II
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Greiner Bio-One North America, Inc.
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.
Sold states
US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
Affected count
495,600 tubes
Manufactured in
4238 Capital Dr, N/A, Monroe, NC, United States
Products
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2024Don't want to check this manually?
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