VACUETTE Blood Collection Tubes Missing Critical Anticoagulant Additive
VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a confirmed manufacturing defect (missing anticoagulant additive) affecting critical laboratory testing. Although no reported illnesses or hospitalizations are documented, the defect poses significant risk of delayed diagnosis or inappropriate treatment through failed or inaccurate test results, meeting the High severity threshold for risk-of-harm products.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE blood collection tubes (Item #454297, 13x75 mm, grey cap with black ring, non-ridged) due to a manufacturing defect affecting lot #A221135N (expiration date 03/02/2024).
The affected tubes are missing anticoagulant/additive material required for proper blood sample collection. Approximately 495,600 tubes have been distributed nationwide to Connecticut, Florida, Iowa, Illinois, Missouri, North Carolina, New York, Pennsylvania, Tennessee, and Virginia.
Missing anticoagulant causes samples to clot in most cases, preventing accurate laboratory results. A completely clotted sample will not produce reportable results, potentially delaying patient diagnosis or treatment. Partially clotted samples may produce incorrect glucose or lactose test results, which could lead to inappropriate medical treatment.
Healthcare providers and laboratories that have received tubes from the affected lot should immediately discontinue their use and follow established protocols for proper sample collection.
The recalled product
- Product
- VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
- Manufacturer
- Greiner Bio-One North America, Inc.
- Hazard
- missing-anticoagulant
- sample-clotting
- test-result-error
- diagnostic-delay
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 (4)
- Lot #A221135N
- Exp. date 03/02/2024
- UDI-DI Case label 39120017575130
- UDI Rack label 29120017575133.
Distribution
Distributed nationwide across the United States.
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