FDA Device recall Z-0393-2018
BD MAX" UVE Specimen Collection Kit
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of BD MAX" UVE Specimen Collection Kit by Becton Dickinson And, citing BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some cus….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0393-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-18 |
| Published | 2018-01-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | n/a |
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.
Reason
BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.
Identifiers
| code_info | UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0393-2018%22
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