Greiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency
Greiner Bio-One is recalling VACUETTE 2mL 9NC Coagulation Tubes because the sodium citrate anticoagulant levels were inconsistent. The recall affects 1,000,800 units distributed nationwide.
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: The recall is classified as FDA Class II. The hazard involves inconsistent anticoagulant levels, which is a quality defect that could affect test results, but no injuries, illnesses, or hospitalizations are reported in the source text.
Plain-English summary
Greiner Bio-One North America, Inc. is recalling VACUETTE 2mL 9NC Coagulation Tubes (Item no. 454322, Lot no. B1908355) because the product was found to have inconsistent amounts of sodium citrate. The source text notes the tubes were shown to have inconsistent amounts of the 2.3% sodium citrate, although the product description lists the concentration as 3.2%.
Approximately 1,000,800 units were distributed nationwide in the United States, including in New Jersey, Indiana, Tennessee, Michigan, North Carolina, Washington, Kansas, California, Louisiana, Illinois, Maryland, New York, Ohio, Texas, Georgia, Kentucky, Pennsylvania, Colorado, Massachusetts, Puerto Rico, Florida, Arkansas, Oklahoma, and Nebraska.
The recall is classified as Class II by the FDA. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the affected lot and distribution scope.
The recalled product
- Product
- VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 1,000,800
Distribution
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