—#160564

Product

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.

FDA product code: NSU — Instrumentation For Clinical Multiplex Test Systems
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K151589
Affected lot / code info: 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.

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 #160564. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.