BD Affirm VPIII Microbial Identification Tests Recalled for Invalid Control Results
Becton Dickinson is recalling 177 kits of BD Affirm VPIII Microbial Identification Tests because they may exhibit invalid internal negative control 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, and the hazard is a potential for invalid test results (false negatives/positives) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 177 kits of BD Affirm VPIII Microbial Identification Tests. The affected products are packaged in kits of 120 tests (Catalog # 446257) and 24 tests (Catalog # 446252). The recall covers specific lots with expiration dates of 12/04/13 and 08/31/13. The products were distributed nationwide.
The recall was initiated because the in vitro diagnostic test kits may exhibit invalid internal negative control results. The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species.
Consumers and healthcare facilities should stop using the affected kits and contact Becton Dickinson for further instructions or a refund.
The recalled product
- Product
- BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 177
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)
- Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13
Distribution
Distributed nationwide across the United States.
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