FDA Device recall Z-0394-2018
BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in…
- FDA Device
- Class II
- terminated
- Published 2018-01-31
On 2018-01-31 the FDA classified a Class II recall of BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in… 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-0394-2018 |
| 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" 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.
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. All *.Catalog number 442970 was originally distributed in Europe only.…UDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. 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-0394-2018%22
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