Intended use: the previ® color gram has been designed to perform automated gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics.Issue description: a customer in france notified biomérieux of staining issues associated with previ color gram instrument v2 - ref.414292, lot 414292202374.The customer indicated that these issues have been ongoing for the last year.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.
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