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Terminated

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 Recall Z-0394-2018 · Posted None

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeNSU
Date Initiated2017-07-18
Date Terminated2018-07-09

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.

Firm 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.

Root Cause

Use error

Distribution Pattern

US and OUS.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151589BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and Company · 2016-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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