Catalog Number 195-160 |
Device Problem
False Positive Result (1227)
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Patient Problems
Diarrhea (1811); Fever (1858); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.
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Event Description
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The consumer reported two (2) false positive results with the binaxnow covid-19 ag self-test performed on her on (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false positive result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022.Confirmation testing was performed at a doctor facility and generated a negative result (platform unknown).The consumer was symptomatic to covid-19 (diarrhea, fever and respiratory symptoms), furthermore consumer stated that even her doctor was confused about the confirmatory test negative result.No additional patient information, including treatment and outcome, was provided.
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Event Description
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The consumer reported two (2) false positive results with the binaxnow covid-19 ag self-test performed on her (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false positive result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022.Confirmation testing was performed at a doctor facility and generated a negative result (platform unknown).The consumer was symptomatic to covid-19 (diarrhea, fever and respiratory symptoms), furthermore consumer stated that even her doctor was confused about the confirmatory test negative result no additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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This supplement report is submitting to retract/correct the initial report that was submitted for false positive, further case review/additional information confirmed that there was no allegation of false positive results against our product.H6 updated, inadvertently omitted from initial report.H3 other text : 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 211622 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 211622, test base part number 195-430h / lot 207659.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 211622 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.H3 corrected h3 other text : device discarded, single use device.
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Event Description
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The consumer reported two (2) false positive results with the binaxnow covid-19 ag self-test performed on her (b)(6)2022.This mfr.Report addresses test one (1) of two (2).The consumer reported a false positive result with the binaxnow covid-19 ag self-test performed on (b)(6)2022.Confirmation testing was performed at a doctor facility and generated a negative result (platform unknown).The consumer was symptomatic to covid-19 (diarrhea, fever and respiratory symptoms), furthermore consumer stated that even her doctor was confused about the confirmatory test negative result no additional patient information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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