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U.S. Department of Health and Human Services

Class 2 Device Recall BD MAX" UVE Specimen Collection Kit

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 Class 2 Device Recall BD MAX" UVE Specimen Collection Kitsee related information
Date Initiated by FirmJuly 18, 2017
Create DateJanuary 19, 2018
Recall Status1 Terminated 3 on July 09, 2018
Recall NumberZ-0394-2018
Recall Event ID 78808
510(K)NumberK151589 
Product Classification Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code NSU
ProductBD 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. 
FEI Number 1119779
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
ActionCustomers 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.
DistributionUS and OUS.
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = NSU
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