Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error
Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II medical device recall with labeling error and no reported injuries or illnesses. The hazard is administrative/labeling-based rather than clinical; no adverse events have been documented.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE TUBE 6 ml K3E K3EDTA blood collection tubes (pink cap, black ring, non-ridged). The affected lot is #B220533J with an expiration date of October 31, 2023.
Some tubes in this lot may be incorrectly labeled, which could cause confusion in clinical laboratory settings. No illnesses or injuries have been reported to date.
The recall affects approximately 36,000 units (30 full cases) distributed nationwide in Wisconsin and Georgia. Healthcare facilities and laboratories that received this product should verify their inventory against the lot number B220533J.
Any facility with affected tubes should discontinue use and contact Greiner Bio-One North America, Inc. for replacement stock or further guidance.
The recalled product
- Product
- greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
- Manufacturer
- Greiner Bio-One North America, Inc.
- Hazard
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 #B220533J
- Exp. 2023-10-31
- UDI Case label (01)39120017576496(17)231031(10)B220533J
- UDI Rack label 29120017576499(17)231031(10)B220533J.
Distribution
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