ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
|
Back to Search Results |
|
Catalog Number 195-160 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2023 |
Event Type
malfunction
|
Event Description
|
The consumer reported inaccurate results on an unknown quantity with binaxnow covid-19 antigen self-tests performed on unknown dates.No additional patient information, including treatment and outcome, was provided.
|
|
Manufacturer Narrative
|
B3: the date provided is an approximation as the exact event date was not provided.The required intake information to enable further investigation, such as the kit's lot number, 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.H3 other text : single use; device discarded.
|
|
Search Alerts/Recalls
|
|
|