ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 10CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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Catalog Number 195-170 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
malfunction
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Event Description
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The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on an unknown date.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Initial testing was performed three (3) times using the binaxnow covid-19 antigen self-test kit, generating negative results.It is unclear if additional testing was performed.No additional information, including treatment and outcome, was provided.
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Manufacturer Narrative
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B3: the date provided is an approximation as the exact event date was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
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Manufacturer Narrative
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B3: the date provided is an approximation as the exact event date was not provided.The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend / unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : single use; device discarded.
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Event Description
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The consumer reported conflicting results with the binaxnow covid-19 antigen self-test kit performed on an unknown date.The first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Initial testing was performed three (3) times using the binaxnow covid-19 antigen self-test kit, generating negative results.It is unclear if additional testing was performed.No additional information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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