In order to identify the true root casuse of this allegation, access bio would need to further communicate with the complainant to rule out potential root causes.However, in the absence of information from the customer it would be difficult to rule out potential root causes identified below.1.Complainant might misinterpret test result 2.Complainant might not follow the instructions for use (ifu) a.Inadequate sample collection b.Interpreting results before 10 minutes c.Not performing test immediately after opening the test device in the pouch d.Potential contact with foreign substances and household cleaning products during sample collection and testing.E.Operating test outsdie of storage conditions f.Excessive buffer application to sample well of test device 3.Complainant might not use the test in accordance with its intended use a.Taking high doses of biotin (>10 mg per day) 4.13% of false negative results are expected based on perfromance characteristics claimed for this test (87% ppa) 5.Tests might be exposed to extreme environmental conitions during storage access bio will continue to monitor further complaints through our data trending programs and take further actions based on identified valid trends.
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