Catalog Number 7D2648 |
Device Problem
False Positive Result (1227)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
B3: the date indicated is an approximation as the exact event date was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
|
|
Event Description
|
The customer reported twenty-three (23) false positive results with the determine hiv 1/2 ag/ab tests performed on unknown dates with unknown sample types.This manufacturer's report addresses test twenty-one (21) of twenty-three (23) and is associated with lot# 237481 (qty 4).The customer indicated that confirmation pcr testing was performed on 1 of the 23 tests on an unknown date and generated a negative result.It is unknown if confirmation or repeat testing was performed for the other 22 results.Although requested, no additional patient information, including treatment and outcome, was provided.
|
|
Event Description
|
The customer reported twenty-three (23) false positive results with the determine hiv 1/2 ag/ab tests performed on unknown dates with unknown sample types.This manufacturer's report addresses test twenty-one (21) of twenty-three (23) and is associated with lot# 237481 (qty 4).The customer indicated that confirmation pcr testing was performed on 1 of the 23 tests on an unknown date and generated a negative result.It is unknown if confirmation or repeat testing was performed for the other 22 results.Although requested, no additional patient information, including treatment and outcome, was provided.
|
|
Manufacturer Narrative
|
B3: the date indicated is an approximation as the exact event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 237481 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 7d2648 / lot 237481 and test base part number 10732998 / lot 237178.The lot met the required release specifications.(b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.
|
|
Search Alerts/Recalls
|