BD AffirM VPIII Microbial Identification Test Recalled for Invalid Results
Becton Dickinson is recalling specific lots of the BD AffirM VPIII Microbial Identification Test because blue speckles or fibers may cause invalid 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. The hazard is a functional defect resulting in invalid test results rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling specific lots of the BD AffirM VPIII Microbial Identification Test. The recall involves 4,502 units distributed worldwide, including nationwide distribution in the United States and Puerto Rico, as well as to Australia, Belgium, India, South Korea, and Singapore.
The recall was initiated because a portion of the tests associated with affected lots 446252 and 446257 may exhibit blue speckles or fibers on the beads and cards. According to the manufacturer, this issue results in an invalid test, as described in the package insert.
Healthcare facilities and users should check their inventory for the affected catalog numbers and batch numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative.
The recalled product
- Product
- BD AffirM VPIII Microbial Identification Test
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 4,502
Distribution
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