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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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 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.Multiple attempts have been made to obtain additional information, with no response from the customer at this time.Eua#: (b)(4).
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Event Description
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It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.Multiple attempts have been made to obtain additional information, with no response from the customer at this time.Eua#:(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 were 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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Search Alerts/Recalls
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