ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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Catalog Number 195-160 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This investigation is still in progress.Once the investigation is completed, a supplemental report will be provided.
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Event Description
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The consumer reported a conflicting result with the binaxnow covid-19 antigen self test otc ,2 test pack.The date of occurrence nor sample type was provided.The initial test performed generated a positive result.Repeat testing was performed and generated a negative result.The consumer did not indicate if the patient was experiencing any symptoms at the time of testing.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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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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