Catalog Number 256082 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Eua # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported while testing for sars-cov-2 a false negative results were obtained.It is unknown what type of confirmation testing was performed.Multiple attempts have been made to obtain additional information, the customer has not responded.Eua # (b)(4).
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Manufacturer Narrative
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H.6.Investigation: this statement summarizes the investigation results regarding the complaints that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 (material # 256082), batch number 0335937.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.A batch review was performed for the number provided.The reported issue was unable to be confirmed.The retention testing could not be tested as they are expired.Returned product testing could not be completed a samples are expired.There are no current trends against false negative or discrepant results.Bd quality will continue to closely monitor for trends.
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Event Description
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It was reported while testing for sars-cov-2 a false negative results were obtained.It is unknown what type of confirmation testing was performed.Multiple attempts have been made to obtain additional information, the customer has not responded.Eua # (b)(4).
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Search Alerts/Recalls
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