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
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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
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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.
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