Becton Dickinson & Co.: Medical Device Recall in 2018 - (Recall #: Z-0392-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 18, 2017

Date Posted: January 31, 2018

Recall Number: Z-0392-2018

Event ID: 78808

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

UDI: 30382904433766. All Lot numbers: Not Distributed in US Not Distributed in US

Distribution Pattern:

US and OUS.

Voluntary or Mandated:

Voluntary: Firm initiated