Becton Dickinson & Co. (BD) has recalled approximately 12,256 units of the BD BACTEC MGIT 960 PZA Kit because it may produce intermittent false resistance results for pyrazinamide (PZA) during tuberculosis testing. These diagnostic kits are used by laboratories to determine if tuberculosis isolates are susceptible to PZA treatment. The recall affects 27 specific production lots of the kit manufactured in the United States and distributed worldwide.
A false resistance result could lead healthcare providers to incorrectly conclude that a patient's tuberculosis infection is resistant to pyrazinamide. This could result in the patient receiving an inappropriate or less effective treatment regimen, potentially prolonging the illness or leading to unnecessary drug toxicity.
IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
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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