Medical device recalls Moderate risk

Becton Dickinson & Co. recalls BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantita…

Recall date
November 6, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0621-2025
FDA classification
Class II
Brand / firm
Becton Dickinson & Co.
Sold / distributed
Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NE, PA and the countries of Canada, Belgium, Singapore, Malaysia.

Why it was recalled

BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263

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