This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The test strips were requested to be returned for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Test strip retention samples 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.".
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