Reported Jan 6, 2021 · Terminated

BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure…

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 Phoenix"
  • PMIC-109IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and
  • gram-positive bacilli Catalog Number448419
Lot codes and dates
  • All unexpired lots UDI00382904484194
Amount recalled
31900 eaches

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection

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 Oct 3, 2023 · Data as of Sep 19, 5:36 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.