D9: device available for evaluation changed to "no".H3: although requested, devices were not returned.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical serum samples.The results were read at 5 and 6 minutes and all devices yielded the expected negative results.No false positive results were observed during in-house testing.Although the tracking number shows that the returned devices were delivered in san diego, a search of the facility did not locate the product.Therefore, testing of returned devices could not be included in the investigation.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 relevant non-conformances and found that the lot met quality control specifications.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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the package insert, this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
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