Investigation conclusion customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg urine control and 3 high level of hcg urine controls (201.4 iu/ml, 203.4 iu/ml and 205.2 iu/ml), all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined from the insufficient information provided and 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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