You work for BlueBelleMed, a company that manufactures a variety of consumer home diagnostic products such as pregnancy tests, ovulation tests, and fertility monitors. BlueBellMed recently learned that one of its home pregnancy testsSimpleblue Kit Pluswas producing an unexpected number of false negative readings. Women would receive the negative reading but then continue to experience symptoms of pregnancy. They would then confirm the pregnancy with a test at their ob/gyn office or through a routine medical visit. BlueBelleMed is not sure what is causing the malfunctions. In general, false negatives are much more likely with home pregnancy tests than are false positives. Some percentage of false negatives result from user error, but the number of reported false negatives for Simpleblue Kit Plus significantly exceeds the number that would be expected. Further, many of the failure reports have documented that the users avoided any of the errors that usually result in the false negatives (e.g. taking the test too early, checking test results too soon, or using diluted urine). A number of similar