Date Initiated by Firm |
July 18, 2017 |
Create Date |
January 19, 2018 |
Recall Status1 |
Terminated 3 on July 09, 2018 |
Recall Number |
Z-0394-2018 |
Recall Event ID |
78808 |
510(K)Number |
K151589
|
Product Classification |
Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code NSU
|
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.
|
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. |
Recalling Firm/ Manufacturer |
Becton Dickinson & Co. 7 Loveton Cir Sparks MD 21152-9212
|
Manufacturer 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 Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NSU and Original Applicant = BECTON, DICKINSON, AND COMPANY
|