ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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Catalog Number 195-160 |
Device Problems
False Positive Result (1227); Output Problem (3005)
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Patient Problems
Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
Event Type
malfunction
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Event Description
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The consumer reported a false positive result with the binaxnow covid-19 ag self-test for a patient performed on (b)(6) 2022 (sample type unknown) pcr confirmation testing (x2) on (b)(6) 2022 (platform: unknown) generated negative results (ct values not provided) the consumer was not symptomatic.However, she had headache no additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded, single use device.
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Manufacturer Narrative
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Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 208757 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160/ lot 208757, test base part number 195-430h / lot 202949.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 208757 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is sample interference or cross contamination.H6 h3 other text : device discarded, single use device.
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Event Description
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The consumer reported a false positive result with the binaxnow covid-19 ag self-test for a patient performed on (b)(6) 2022 (sample type unknown).Pcr confirmation testing (x2) on (b)(6) 2022 (platform: unknown) generated negative results (ct values not provided).The consumer was not symptomatic.However, she had headache.No additional patient information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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