BD Microtainer Tubes Recalled Due to Reduced Anticoagulant Additive
Becton Dickinson is recalling specific Microtainer tubes because they may contain reduced or no additive, causing blood samples to clot and delaying test 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: The recall is classified as FDA Class II and involves a risk of harm (delayed patient treatment due to sample clots) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling BD Microtainer Tubes with BD Microgard Closure and K2EDTA additive, Model Numbers 365974 and 365975. The recall affects approximately 1,707,804 units distributed to healthcare facilities in Alabama, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Puerto Rico.
The FDA has confirmed that the affected tubes have reduced or no additive within the tube reservoir. This defect may cause visible clots or micro-clots to form in the blood samples. These clots can be difficult to detect during visual inspection.
Clotted samples may require healthcare providers to recollect samples or retest patients. This process can result in delayed reporting of test results and delayed patient treatment. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the foll
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 1,707,804
Distribution
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