Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Defect was detected per qc investigation on 11/27/2019: discolored chemistry, lo, and e-5.Most likely underlying root cause: rc-061 storage outside specifications.Rc-072: vial left open for an extended period of time, rc-069: missing chemistry; user washed strips.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
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