Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg cutoff urine control and 3 high level of hcg urine controls (201.4 iu/ml, 204.2 iu/ml and 212.2 iu/ml), all results were hcg positive at read time and met qc specification.No false negatives were obtained.Mfg batch record review did not uncover any abnormalities.Root cause could not be determined due to insufficiency information provided by customer 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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