Becton Dickinson & Co.: Medical Device Recall in 2018 - (Recall #: Z-0394-2018)

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 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.

Product Classification:

Class II

Date Initiated: July 18, 2017

Date Posted: January 31, 2018

Recall Number: Z-0394-2018

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: 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.

Distribution Pattern:

US and OUS.

Voluntary or Mandated:

Voluntary: Firm initiated