Reported Jan 24, 2024 · Ongoing

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

Greiner Bio-One North America, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Greiner Bio-One North America, Inc. · 4238 Capital Dr · Monroe, NC · 28110-7681

Is this the product you have?

  • VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Lot codes and dates
    • Lot #A221135N
    • Exp. date 03/02/2024
    • UDI-DI Case label 39120017575130
    • UDI Rack label 29120017575133
Amount recalled
495,600 tubes

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 PM UTC

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