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 12/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 2 false positive results were obtained as part of an moh validation study.The customer stated there was no patient impact as this was a ruo context.No additional information has been provided by the customer at this time.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 the complaint that alleges invalid result when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch number 0255648.Bd quality performs a systematic approach to investigate invalid result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Retention testing was performed on the batch number provided.No issues were found.A batch history review could not be completed as it was unavailable.The reported issue was unable to be confirmed.However, there is a trend against false positive results.Bd has initiated corrective and preventive action to further investigate.Bd quality will continue to closely monitor for trends.
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Event Description
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It was reported while testing for sars cov-2 2 false positive results were obtained as part of an moh validation study.The customer stated there was no patient impact as this was a ruo context.No additional information has been provided by the customer at this time.Eua#: (b)(4).
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Search Alerts/Recalls
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