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Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/05/2024 |
Event Type
malfunction
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Event Description
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An anonymous consumer posted on twitter stating, 'can anecdotally confirm that accuracy issue w/ intelliswab rats.Gave me my first false positive yesterday (oral/nasal combo swab.) disconfirmed with 2 negatives via at-home pcr (metrix, nasal, 30m later) and binax rat 24hrs later (triple swab.)' refer to the attached twitter post.Oti marketing department replied to the consumer's twitter post advising they email oti so we can reach out to them directly for additional information.As stated in the inteliswab covid-19 rapid test ifu, 'important: swabbing the nostrils is critical for obtaining an accurate result.If you do not swab your nose, the device will produce a false negative result.'.
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Event Description
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An anonymous consumer posted on twitter stating, 'can anecdotally confirm that accuracy issue w/ intelliswab rats.Gave me my first false positive yesterday (oral/nasal combo swab.) disconfirmed with 2 negatives via at-home pcr (metrix, nasal, 30m later) and binax rat 24hrs later (triple swab.)' refer to the attached twitter post.Oti marketing department replied to the consumer's twitter post advising they email oti so we can reach out to them directly for additional information.As stated in the inteliswab covid-19 rapid test ifu, 'important: swabbing the nostrils is critical for obtaining an accurate result.If you do not swab your nose, the device will produce a false negative result.'.
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Manufacturer Narrative
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The consumer commented on twitter reporting false positive inteliswab test results only while using the device against the ifu.Oti marketing responded to the consumer's twitter comment advising them to email more information to technicalservice@orasure.Com.The consumer has not provided a lot number or any additional information to date.No additional follow up is to be expected with this complaint and the incident will be closed internally.
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Search Alerts/Recalls
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