Coagulation blood tubes recalled over a misplaced label shifting the fill mark
Greiner Bio-One is recalling 504,000 VACUETTE 2 ml coagulation tubes because the label was applied too high, shifting the printed fill level mark upward.
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: Scored 2 as a labelling error: the only stated consequence is unnecessary sample rejection and repeat collection, not an erroneous result.
Plain-English summary
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2% blood collection tubes, REF 454322, are being recalled.
The tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward. The firm states this could result in unnecessary sample rejection and repeat collections.
The recall covers 504,000 tubes from lot B250139Q, expiring 9 January 2026, carrying rack UDI-DI 29120017574488 and case UDI-DI 39120017574485. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the labelling defect and reports no injuries. Laboratories and collection sites holding the affected lot should follow the firm's instructions.
The recalled product
- Product
- Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 504,000
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 (3)
- UDI-DI: 29120017574488(Rack)
- 39120017574485(Case). Lot: B250139Q
- Expiration: 01/09/2026
Distribution
Distributed nationwide across the United States.
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