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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 Kit see related information
Date Initiated by Firm July 18, 2017
Create Date January 19, 2018
Recall Status1 Terminated 3 on July 09, 2018
Recall Number Z-0393-2018
Recall Event ID 78808
Product Classification Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code NSU
Product BD MAX" UVE Specimen Collection Kit.
Catalog Number(s): 443376 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 when used with catalog 443712, 443824 and 442970.
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
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.
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