This mdr is a retrospective filing that was identified during an internal assessment as part of capa (b)(4) related to unmonitored communications channels (e-mails, voicemails).Investigation results: it is indicated that the product is not returning for evaluation.A lot number of the test strip product was not provided and neither manufacturing record review nor testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing inratio® test strips and monitors.In addition, all alere inratio® test strips are now expired.Customers have been advised to work with their healthcare provider to transition to an alternate monitoring method, such as a plasma-based laboratory inr method or a point-of-care monitoring system from a different manufacturer.
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It was reported by the customer that there were difficulties with the new device or the test strips.When the values were compared to the old device, the new device values deviated by two units the first time, four units the second then six units.No comparison lab values or results were provided.No adverse events were reported.There was also difficulties opening the test strip pouch at the perforation.No other information is available.
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