Additional information: update to d10: device available for evaluation changed to no.Update to h3: although returned devices were requested, customer did not return devices for investigation.Update to h6: method code 11 added.Result code 213 added.Conclusion code 67 added.Investigation conclusion: retained product from the reported lot number was tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded the expected negative result.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.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.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.A root cause could not be determined from the available information, as the reported issue was not replicated during testing of retention product.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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