BD MAX UVE Specimen Collection Kit Recalled for Test Result Issues
Becton Dickinson is recalling the BD MAX UVE Specimen Collection Kit because it may cause unresolved or indeterminate test results, potentially requiring re-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 describes a functional issue leading to non-reportable results rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling the BD MAX UVE Specimen Collection Kit, Catalog Number 443376. This product is used for the collection and transport of vaginal and endocervical swab specimens, as well as the preservation of urine from males and females.
The recall was initiated after the company notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAX Vaginal Panel. The source text notes that a non-reportable result may lead to a repeat of the test and/or re-collection of a specimen.
The affected units are distributed in the US and outside the US (OUS). The recall applies to all lot numbers when the kit is used with catalog numbers 443712, 443824, and 442970. The UDI for the product is 30382904433766.
The recalled product
- Product
- BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 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
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 (2)
- UDI: 30382904433766. All Lot numbers: All when used with catalog 443712
- 443824 and 442970.
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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