Blood tubes recalled after being manufactured without the gel separator
Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.
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: Scored 3 under the risk-of-harm criterion: the firm states missing gel separator can yield erroneous results and delay diagnosis, and no injuries are reported.
Plain-English summary
The Greiner VACUETTE 8 ml CAT Serum Separator Clot Activator blood collection tube (16 x 100 mm) with standard stopper, catalog number 455071P, is being recalled.
Some tubes were manufactured without the gel separator. Greiner states this could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing, which may result in delayed diagnosis, cause a delay in clinical decision-making or treatment, and in some rare cases yield incorrect results from less stable parameters.
The recall covers 1,980,000 tubes from lot B250437N, carrying UDI-DI 29120017573061. The product was distributed across the United States. The FDA has classified the action as Class II.
Laboratories and collection sites holding the affected lot should follow Greiner's instructions.
The recalled product
- Product
- Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
- Manufacturer
- Greiner Bio-One North America, Inc.
- Affected units
- 1,980,000
Distribution
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