Reported Mar 8, 2017 · Terminated

BD AffirM VPIII Microbial Identification Test

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 AffirM VPIII Microbial Identification Test
Lot codes and dates
  • Catalog Number Batch Number
    • 446252
    • 5126980
    • 5135673
    • 5138774
    • 5140625
    • 5142767
    • 5153674
    • 5153675
    • 5224882
    • 446257
    • 5141655
    • 5148857
    • 5156873
    • 5173648
Amount recalled
Qty Distributed to Field - 4,502

Where it was sold

Why it was recalled

BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.

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 Mar 6, 2017 · Data as of Sep 19, 4:46 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.