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 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device lot #: 0256738 was reported, however, this is not a lot# manufactured for this product #.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).
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Event Description
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It was reported while testing for sars cov-2 3 false positive results were obtained.Repeat tests were performed using pcr and the results were negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no indication that results were reported out and 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 3 false positive results were obtained.Repeat tests were performed using pcr and the results were negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no indication that results were reported out and there was no report of patient impact.Eua#: (b)(4).
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Manufacturer Narrative
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H.6.Investigation: this memo 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 not valid.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 could not be performed as an incorrect batch number was provided.The complaint was unable to be confirmed.However, there is a trend against false positive results.Bd has initiated capa#1878253 to further investigate.Quality will continue to closely monitor for trends.
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Search Alerts/Recalls
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