BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Results
Becton Dickinson is recalling BD MAX CT/GC/TV kits due to increased rates 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. The source text describes a performance issue (unresolved/indeterminate results) that may lead to repeat testing, but does not report hospitalizations, significant injuries, or fatalities. This aligns with the 'Moderate' severity criteria for low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Becton Dickinson & Co. is recalling the BD MAX CT/GC/TV medical device, used for the collection and transport of vaginal and endocervical swab specimens and preservation of urine. The recall affects catalog numbers 443824, 442970, and 443590. The product was distributed in the US and outside the US.
The recall was initiated because customers reported an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAX Vaginal Panel. This issue was communicated to customers in July 2017. These non-reportable results may lead to the need for repeat testing or re-collection of specimens.
No specific illnesses or injuries are reported in the source text. The hazard is related to the performance of the diagnostic test, potentially leading to delayed or repeated diagnostic procedures.
The recalled product
- Product
- BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (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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