Recall Z-0394-2018— Becton Dickinson & Co.

Name: FDA recall Z-0394-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-18

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2017-07-18, terminated 2018-07-09. It names one FDA 510(k) clearance: K151589. 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2017-07-18
Terminated: 2018-07-09
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and Company·cleared 2016-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.