Greiner Bio-One North America, Inc. recalls 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolyti…

Recall date

April 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1923-2016

FDA classification

Class II

Brand / firm

Greiner Bio-One North America, Inc.

Sold / distributed

Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico

Why it was recalled

The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate