Becton Dickinson & Co. (BD) is recalling 13,190 units of BD BBL Sensi Disc Ampicillin 2 µg (AM-2) in-vitro diagnostic tests because they may have lost up to 65% of their potency over 18 months. This potency loss was discovered during stability testing and can cause the product to give false test results. Specifically, the test may incorrectly indicate that bacteria are resistant to the antibiotic ampicillin when they are not. No incidents or injuries have been reported to date. Consumers and laboratory personnel should stop using the affected test discs immediately and contact BD to arrange for a return or replacement.
The loss of potency can cause false resistant results during susceptibility testing, which is used to determine which antibiotics will effectively treat an infection. This could lead to patients being denied effective treatment or being given more powerful, unnecessary antibiotics based on incorrect lab data.
Used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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