Internal report: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Defects were detected.Most likely underlying root cause: rc-060: user washed strips.Rc-061: storage outside specifications.Rc-069: missing chemistry; user washed strips.Rc-072: vial left open for an extended period of time.Rc-076: mishandled by end user.Test strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the products are performing as intended - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
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