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 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 approximately eight (8) false positive results were obtained.Repeat tests were performed using a pcr test method and the results were negative.The customer stated the patients tested were asymptomatic.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 or any report of patient impact.(b)(4).
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Manufacturer Narrative
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Investigation: bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.The investigation did not find a root cause for the false positive results that was observed.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.
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Event Description
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It was reported while testing for sars cov-2 approximately eight (8) false positive results were obtained.Repeat tests were performed using a pcr test method and the results were negative.The customer stated the patients tested were asymptomatic.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 or any report of patient impact.(b)(4).
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Search Alerts/Recalls
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