BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD CALIBRITE 3 BEADS; COUNTER, DIFFERENTIAL CELL
|
Back to Search Results |
|
Model Number 340486 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/03/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported that while using bd calibrite¿ 3 beads there was a failure for fl3.Patient impact was not reported.The following information was provided by the initial reporter, translated from spanish to english: in all cases we obtain failure result for fl3.
|
|
Manufacturer Narrative
|
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00335 was sent in error.Patient sample was not used when running, therefore, this is not considered to be a reportable malfunction.
|
|
Event Description
|
It was reported that while using bd calibrite¿ 3 beads there was a failure for fl3.Patient impact was not reported.The following information was provided by the initial reporter, translated from spanish to english: in all cases we obtain failure result for fl3.
|
|
Search Alerts/Recalls
|
|
|