Catalog Number 256082 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Information (3190)
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Event Date 10/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Eua # (b)(4).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 the customer questioned the accuracy of the test in response to a survey the customer received.Multiple attempts have been made to obtain additional information, the customer has not responded.Eua # (b)(4).
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Event Description
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It was reported while testing for sars-cov-2 the customer questioned the accuracy of the test in response to a survey the customer received.Multiple attempts have been made to obtain additional information, the customer has not responded.Eua # (b)(4).
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Manufacturer Narrative
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Eua#: (b)(4).Investigation summary: 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.Due to unknown lot# a dhr could not be performed.The investigation did not find a root cause for the false positive results that were observed.It is recommended that each customer review their workflow carefully to ensure that the package insert is being followed as written.The root cause is under investigation and will be documented in our quality system.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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