Recall Z-0394-2018 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Becton Dickinson & Co.
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.
| Date | Jul 18, 2017 |
| Status | Terminated |
| 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. |
| Root cause | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151589 | BD MAX CT/GC/TV, BD MAX INSTRUMENT Becton, Dickinson and Company, Sep 6, 2016 |