Investigation conclusion customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg cutoff urine control and 100 miu/ml hcg urine control; 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.The root cause could not be determined based on the information provided by the 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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