—#160563

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.

FDA product code: NSU — Instrumentation For Clinical Multiplex Test Systems
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: UDI: 30382904433766. All Lot numbers: All when used with catalog 443712, 443824 and 442970.

Why it was recalled

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 (FDA determination)

Use error

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: US and OUS.

Timeline

Recall initiated: 2017-07-18
Terminated: 2018-07-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160563. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.