Investigation conclusion update: customer's observation was not replicated in-house with retention and return devices.Retention devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls (203.4 iu/ml, 208.6 iu/ml and 216.8 iu/ml), all results were hcg positive at read time.No false negatives were obtained.Return products were tested with hcg 20 miu/ml cutoff urine control and high level 201.8 iu/ml hcg urine control, all results were positive, no false results were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
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