Z-0394-2018Class II

BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and...

Name: Z-0394-2018 BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and...
Creator: Becton Dickinson & Co.
Published: 2017-07-18
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-07-18 / Terminated

FDA source

Becton Dickinson & Co. began a 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 addition to the... on 2017-07-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0394-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-18
Posted: 2018-01-19
Terminated: 2018-07-09
Recalling firm: Becton Dickinson & Co
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.
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
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.
FDA root cause: Use error
Action: Customers were notified via UPS on 07/18/2017. The recall for BD MAX" Vaginal Panel and BD MAX" UVE Specimen Collection Kit was initiated on July 18, 2017 and expanded to include BD MAX" CT/GC/TV on August 11, 2017. The recall expansion letter to customers was dated 08/14/2017.
Distribution: US and OUS.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0394-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0392-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19
Z-0393-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19
Z-0394-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19

Product code NSU

K151589Class IIBd Max Ct/gc/tv, Bd Max InstrumentBecton, Dickinson and Company / cleared 2016-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)