Microbiologics Inc is recalling four units of the KWIK-STIK ANA (3 Strains) QC Set because the product is missing one of its required microbiological strains, specifically the 6018P Parabacteroides distasonis. This quality control set is used for microbiological testing, and the absence of a required component could lead to inaccurate laboratory results. These sets were distributed to laboratories in Minnesota, Pennsylvania, Tennessee, and Texas.
The missing strain in this diagnostic quality control kit can lead to false-negative results or the inability to verify the performance of laboratory tests, potentially impacting clinical decisions or research based on those tests.
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Sources: FDA iRES · Raw API Response
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