Model Number 256045 |
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 01/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 with kit flu a+b 30 test physician veritor false positive results were obtained.Confirmatory testing was performed using pcr test method and the results were negative.Multiple attempts have been made to obtain additional information, the customer has not responded.
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Manufacturer Narrative
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H6: investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges false positive results when using kit flu a+b 30 test physician veritor (mn# 256045), batch number 0080443.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 and testing were performed on the batch number provided.The reported issue was unable to be confirmed.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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Event Description
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It was reported while testing with kit flu a+b 30 test physician veritor false positive results were obtained.Confirmatory testing was performed using pcr test method and the results were negative.Multiple attempts have been made to obtain additional information, the customer has not responded.
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Search Alerts/Recalls
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