No product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." e3 - occupation was patient/consumer.
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There was an allegation of questionable results from the coaguchek inrange meter.On (b)(6) 2023, the result from a laboratory using ac chronometric reagent was 3.28 inr.The result from the meter was 4.9 inr.On (b)(6) 2023, the result from a laboratory using ac chronometric reagent was 4.28 inr.The result from the meter was 6.0 inr.The timeframe between the comparison tests was not provdied.The therapeutic range: was 2.5-3.5 inr.
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