Meridian Bioscience Inc has recalled 109 units of its Alethia C. Difficile and Group B Streptococcus (GBS) Nucleic Acid Amplification Test Assays. The recall was issued because the caps on the reaction buffer tubes may be missing a black rubber gasket, which can cause the buffer solution to leak and results in a lower volume than required for the test. This defect was discovered by the manufacturer and could potentially interfere with the accuracy of medical diagnostic testing.
If the buffer tube leaks due to a missing gasket, there may not be enough solution to properly perform the diagnostic test. This could result in incorrect or invalid test results for patients being screened for C. difficile or Group B Streptococcus infections.
Recall #: Z-0568-2026
Recall #: Z-0569-2026
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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