BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Test Results
Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.
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, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is limited to non-reportable test results requiring repeat testing.
Plain-English summary
Becton Dickinson & Co. is recalling the BD MAX Vaginal Panel, a medical device used for the collection and transport of vaginal and endocervical swab specimens and the preservation of urine. The recall involves catalog numbers 443712, 443710, and 443711. The product was distributed in the United States and outside the United States.
The recall was initiated because the manufacturer notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the device. These non-reportable results may lead to the need for repeat testing and/or re-collection of specimens.
The source text does not specify the number of affected units or report any illnesses or injuries. Consumers and healthcare providers should contact Becton Dickinson & Co. for further instructions regarding the recall.
The recalled product
- Product
- BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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