Greiner Bio-One Recalls Coagulation Blood Collection Tubes Due to Concentration Error
Greiner Bio-One is recalling specific lots of 3mL coagulation blood collection tubes because a lower citrate concentration may cause falsely low 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 a diagnostic error (falsely low values) rather than a direct physical injury or high-risk pathogen, fitting the 'Moderate' criteria for low-risk contamination or labeling errors.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling 838.9 cases (1,006,700 pieces) of 3mL 9NC Coagulation Sodium Citrate 3.2% blood collection tubes, Item #454334. The affected product is identified by Lot #B041206 and was distributed nationwide.
The recall was initiated because part of the lot received a lower concentration of citrate solution. This defect may cause falsely lower values for common coagulation tests, potentially affecting the accuracy of medical diagnostics.
Healthcare facilities and distributors should stop using the affected tubes and contact the manufacturer for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
- 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 #B041206
Distribution
Distributed nationwide across the United States.
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