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 11/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, 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 positive result was obtained.Confirmatory testing was performed using pcr test method and the result was negative.There was no report of patient impact.Customer has stated no additional details will be provided.Eua # (b)(4).
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Manufacturer Narrative
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H.6.Investigation: this statement summarizes the investigation results regarding the complaint that alleges false positive results when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch 0236112.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Investigations were performed on the batch number 0236112 and no relevant issue was found.Retention sample testing was not performed on batch number 0236112 because the material was past its expiration date.Bd makes no claims on expired products and stability studies have shown the use of expired materials may affect the sensitivity of the assay.Therefore, materials past expiry will not be tested.A trend was identified for false positive results.Based on the trend, capa#1878253 was initiated.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 positive result was obtained.Confirmatory testing was performed using pcr test method and the result was negative.There was no report of patient impact.Customer has stated no additional details will be provided.Eua # (b)(4).
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Search Alerts/Recalls
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