The meter and strips have been requested for return.The 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." initial reporter - occupation was patient/consumer.
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There was an allegation of questionable results from a coaguchek xs meter.The serial number was requested but was not known.The result from the meter, possibly in the morning, was allegedly 2.2 inr.The result from the hospital laboratory when he arrived was reportedly 4.7 inr using an unknown reagent.The actual time between the meter and laboratory testing could not be provided.The therapeutic range was 2.5-3.5 inr.Additional information was requested but the reporter refused to provide any further information.
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