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 01/20/2021 |
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 result was obtained.Confirmatory testing was performed using pcr test method and the result was positive.Patient self quarantined while waiting for pcr results.Eua # (b)(4).
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Manufacturer Narrative
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H6: investigation summary: 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 0293950.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.Investigation and testing were performed on the batch numbers 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.
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Event Description
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It was reported while testing for sars-cov-2 a false negative result was obtained.Confirmatory testing was performed using pcr test method and the result was positive.Patient self quarantined while waiting for pcr results.Eua # (b)(4).
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Search Alerts/Recalls
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