Investigation conclusion: an investigation was performed on retention products for the reported lot number.Retention products were tested with clinical negative serum sample and low concentration serum standards (2 miu/ml hcg).Results were read at 5 and 6 minutes and all test devices produced expected negative results.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any abnormalities.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.Review of the information provided did not identify any evidence of misuse.There is no indication that the customer deviated from the package insert.The reported hcg concentration for the serum specimen was 5.1 miu/ml.This test is designed to detect hcg concentrations of 10 miu/ml or greater in serum and 20 miu/ml or greater in urine.Due to the high sensitivity of this test, the presence of hcg below these concentrations may produce positive results.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy should only be made by a physician after all clinical and laboratory findings have been evaluated.Product discarded by customer.
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