Reported Jan 31, 2018 · Terminated

BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical…

Becton Dickinson & Co.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212

Is this the product you have?

  • 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
Lot codes and dates
  • UDI30382904433766
  • All Lot numbers
    • All when used with catalog 443712
    • 443824 and 442970
Amount recalled
N/A

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 9, 2018 · Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.