Catalog Number RCHM-02071 |
Device Problems
False Positive Result (1227); Output Problem (3005); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2023 |
Event Type
malfunction
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Event Description
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The subject #1 of 2 that laboratorio clinico coamo reported as receiving false positive (pink line in the test area) on nov 18, 2023.On nov 20, 2023, test was repeated again with the same lot and same result was obtained.
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Manufacturer Narrative
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Potential root causes for false positive were identified and listed below: the technical support team at access bio tested the returned lot# ch23f01 which provided acceptable results for both positive and negative samples.Moreover, the support team at accessbio also ran clinical study by testing on 5 randomly different employees, the result came out fine without any issues.1.Complainant might misinterpret test results.2.Complainant might not follow the instructions for use (ifu) a.Inadequate sample collection (excess blood or mucus on swab).B.Interpreting result after 15 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 outside of storage conditions.F.Excessive buffer application to sample well of test device.3.0.68% of false positive results are expected based on performance characteristics claimed for this test (npa: 99.32%) access bio will continue monitor further complaints through our data trending program and take further actions based on identified valid trends.
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Search Alerts/Recalls
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