ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW¿ COVID-19 ANTIGEN SELF TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
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Catalog Number 195-160 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2021 |
Event Type
Injury
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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 adverse reactions after using binaxnow¿ covid-19 antigen self test performed on (b)(6) 2021.Consumer stated that after swabbing the nose they experienced sever vertigo, nausea, diarrhea, migraine headache and occasional rapid heart rate.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 and logfiles, 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.Based on the above summary the investigation is deemed complete.The product will continue to be monitored and tracked.
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Search Alerts/Recalls
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