FDA Device recall Z-0392-2018
BD MAXTM Vaginal Panel
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of BD MAXTM Vaginal Panel 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-0392-2018 |
| 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 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.
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: Not Distributed in US Not Distributed in US |
|---|
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-0392-2018%22
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