Greiner Bio-One Recalls 4 ml FX Sodium Fluoride Tubes
Greiner Bio-One is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes because they may contain low or no additives, potentially affecting glucose and lactate test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to potential inaccuracies in analytical results rather than direct physical injury or illness, fitting the criteria for a moderate severity issue.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling 4 ml FX Sodium Fluoride/Potassium Oxalate tubes (Ref 454297) due to a potential manufacturing defect. The recalled VACUETTE Glycolytic Inhibitor Tubes may contain low or no additive, specifically sodium fluoride and potassium oxalate.
The presence of these additives is necessary for the accurate analysis of blood glucose and lactate. If the additives are missing or present in low quantities, the analytical results for these tests may be affected. The recall involves 250,800 pieces (209 cases) from Lot A151137L.
The affected products were distributed nationwide to California, Florida, Illinois, Kentucky, New York, Pennsylvania, Virginia, and Puerto Rico. Users of these tubes should check their inventory for the specific lot number and discontinue use of any affected units.
The recalled product
- Product
- 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
- Manufacturer
- Greiner Bio-One North America, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot A151137L
Distribution
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