Model Number 20402 |
Device Problems
No Apparent Adverse Event (3189); Erratic Results (4059)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/19/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation conclusion: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Root cause: unable to determine.Source: phone.
|
|
Event Description
|
Reported discrepant sars results for 1 consumer.It is unknown if the consumer was symptomatic.The consumer communicated that they tested positive with quickvue otc and negative with another at-home antigen assay the same day.No confirmatory testing had been completed.
|
|
Manufacturer Narrative
|
Correction:
b4 - added today's date of the follow-up correction report
g3 - corrected the awareness date.
|
|
Search Alerts/Recalls
|