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 12/08/2020 |
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 positive result was obtained.Confirmatory testing was performed using pcr test method and the result was negative.The customer stated they are testing asymptomatic staff members.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no report of patient impact.Eua # (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.The customer stated they are testing asymptomatic staff members.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no report of patient impact.Eua # (b)(4).
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Manufacturer Narrative
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H6: investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges false positive results when using kit rapid detection of sars-cov-2 veritor (material # 256082 ), batch number 0316883.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.An investigation was performed on the batch number provided.The reported issue was unable to be confirmed.However, there is a trend against false positive results.Bd has initiated capa (corrective and preventive action) # 1878253 to further investigate.The root cause could not be identified.Bd quality will continue to closely monitor for trends.H3 other text : see h10.
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Search Alerts/Recalls
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