Device Problem
Insufficient Information (3190)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 03/12/2024 |
Event Type
malfunction
|
Event Description
|
A consumer posted on twitter stating, 'i'm absolutely shocked that i tested +ve for the 1st time ever today, especially since i've been isolated for a month + always wear an aura outside my apt.Negative on lucira, cue + some off-brand free gov rat.Pos on expired inteliswab.' refer to the attached twitter comment.
|
|
Manufacturer Narrative
|
The consumer posted on twitter stating they received false positive test results using an expired inteliswab test.Specific details of the collection and testing process of the inteliswab test was not provided.The consumer also did not provide a lot number to confirm whether this lot's expiration date was extended or was confirmed expired.The consumer stated they tested negative on other brand rapid tests, but it is unknown if a pcr test was taken to confirm the test results.Orasure technologies, inc.Is unable to contact the consumer for additional information as no contact information is available on twitter.No additional follow up is to be expected with this complaint and the incident will be closed internally.
|
|
Event Description
|
A consumer posted on twitter stating, 'i'm absolutely shocked that i tested +ve for the 1st time ever today, especially since i've been isolated for a month + always wear an aura outside my apt.Negative on lucira, cue + some off-brand free gov rat.Pos on expired inteliswab.
|
|
Search Alerts/Recalls
|