Model Number 337146 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/26/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that while using bd facs¿ lyse wash assistant that the amount of cells retrieved is lower than expected.The following information was provided by the initial reporter.The customer reports that the amount of cells retrieved is lower than expected.
|
|
Manufacturer Narrative
|
Device evaluation by mfr is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2022-00300 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
|
|
Event Description
|
It was reported that while using bd facs¿ lyse wash assistant that the amount of cells retrieved is lower than expected.The following information was provided by the initial reporter.The customer reports that the amount of cells retrieved is lower than expected.
|
|
Search Alerts/Recalls
|