Catalog Number 443812 |
Device Problem
False Positive Result (1227)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/08/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
D.4.Medical device lot/expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H3 other text : na.
|
|
Event Description
|
5 of 5 it was reported that samples in kit bd max ext enteric bacterial panel gave false positive results: run 1133, a2 no patient impact was reported.
|
|
Manufacturer Narrative
|
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.There was no report of serious injury, medical information, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
|
|
Event Description
|
Additional information received: bd quality engineer determined that there was no false positive result for run 1133 on a1.
|
|
Search Alerts/Recalls
|