Microbiologics Inc recalls Vaginal Verification Panel Ref 8208 Lot 8208-11
Recalled Product
Vaginal Verification Panel Ref 8208 Lot 8208-11
Hazard / Issue
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
Issued by
FDA
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