Catalog Number 20402 |
Device Problems
False Positive Result (1227); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Event Description
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Customer reporting a potential false positive sars result.No conflicting test result occurred and no confirmation testing was performed.The customer feels they should be negative because they are asymptomatic.Through interview it was found the customer was using an expired kit.
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Manufacturer Narrative
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Investigation conclusion:.In response to your complaint, we performed a review of the package insert (pi) for clarity of instructions.No issues were found.The reported problem we believe is related to a deviation from the instructions called out in the pi.Expired product used.The company makes no claims for the functionality of products beyond their expiration date.Root cause: unable to determine / possible expired product use.Source: phone.
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Manufacturer Narrative
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Updates made: b4; date of report ; updated to today's date.Update made to source: website.
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Search Alerts/Recalls
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