Catalog Number 256082 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
No Information (3190); Insufficient Information (4580)
|
Event Date 10/13/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported while testing for sars cov-2 2 false negative results were obtained.Repeat tests were performed using pcr and the results were positive.Multiple attempts have been made to obtain additional information, with no response from the customer at this time.Eua#: (b)(4).
|
|
Manufacturer Narrative
|
H6: investigation summary this memo is to summarize the investigation results regarding your complaints that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 (mn# (b)(4)), batch number unknown.Bd quality performs a systematic approach to investigate false negative complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.The investigation could not be performed as no batch number was provided.The complaint was unable to be confirmed.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.
|
|
Event Description
|
It was reported while testing for sars cov-2 2 false negative results were obtained.Repeat tests were performed using pcr and the results were positive.Multiple attempts have been made to obtain additional information, with no response from the customer at this time.Eua#: eua(b)(4).
|
|
Search Alerts/Recalls
|