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 Problems
False Positive Result (1227); Poor Quality Image (1408)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use device, discarded.
|
|
Event Description
|
Customer reported an unconfirmed false positive result using the binax now covid-19 ag self test performed on (b)(6) 2022.Customer also reported taking a negative test result on (b)(6) 2022 with an unknown test brand.Confirmation testing was not performed, and no symptoms were reported.No additional patient information, including treatment and outcome, was provided.The customer did not report any patient harm due to the results.Additionally, the customer did not report any delay or impact in treatment.
|
|
Event Description
|
Customer reported an unconfirmed false positive result using the binax now covid-19 ag self test performed on (b)(6) 2022.Customer also reported taking a negative test result on (b)(6) 2022 with an unknown test brand.Confirmation testing was not performed, and no symptoms were reported.No additional patient information, including treatment and outcome, was provided.The customer did not report any patient harm due to the results.Additionally, the customer did not report any delay or impact in treatment.
|
|
Manufacturer Narrative
|
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 211897 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160 / lot: 211897, test base part number 195-430h / lot: 207615.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 211897 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to the specific patient sampled4: expiration date extended to 25apr2024.E1: na for phone number h6: medical device problem code changed to a090804 h3 other text : single use device, discarded.
|
|
Search Alerts/Recalls
|
|
|