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 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device lot #: 0279956 was reported, however, this is not a lot# manufactured for this product #.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported while testing for sars cov-2 two (2) false positive results were obtained.Repeat tests were performed using a pcr test method and the results were negative.There was no indication that results were reported out or any report of patient impact.(b)(4).
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Event Description
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It was reported while testing for sars cov-2 two (2) false positive results were obtained.Repeat tests were performed using a pcr test method and the results were negative.There was no indication that results were reported out or any report of patient impact.Eua(b)(4).
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Manufacturer Narrative
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H.6.Investigation: this statement is to summarize the investigation results regarding tihe complaint that alleges false positive results when using kit rapid detection of sars-cov-2 veritor (material # 256082 ), batch number unknown.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 no batch number, or an incorrect batch number was provided.The complaint was unable to be confirmed.Quality will continue to closely monitor for trends.H3 other text : see h.10.
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Search Alerts/Recalls
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