Catalog Number 195-160 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2024 |
Event Type
malfunction
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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.
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Event Description
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The consumer reported four (4) false positive results with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024.This mfr.Report addresses test three (3) of four (4).The customer reported a false positive result with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024 on an unknown sample type.Additional testing was performed at the doctor¿s office on an unknown date via an unknown method which generated a negative result.No additional information, including treatment and outcome, was provided.
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Event Description
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The consumer reported four (4) false positive results with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024.This mfr.Report addresses test three (3) of four (4).The customer reported a false positive result with the binaxnow covid-19 antigen self-test performed on or before (b)(6) 2024 on an unknown sample type.Additional testing was performed at the doctor¿s office on an unknown date via an unknown method which generated a negative result.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 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, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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Search Alerts/Recalls
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