Catalog Number 44500301 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Eua# (b)(4).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 that while testing for sars-cov-2 false positive results occurred.Samples were repeated by laboratory personnel and were negative.There was no report of patient impact.(b)(4).
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 0168224.D.4.Medical device expiration date: 2020-12-29.H.4.Device manufacture date: 2020-06-16.D.4.Medical device lot #: 0168233.D.4.Medical device expiration date: 2021-01-04.H.4.Device manufacture date: 2020-06-16.
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Event Description
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It was reported that while testing for sars-cov-2 false positive results occurred.Samples were repeated by laboratory personnel and were negative.There was no report of patient impact.(b)(4).
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Event Description
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It was reported that while testing for sars-cov-2 false positive results occurred.Samples were repeated by laboratory personnel and were negative.There was no report of patient impact.Eua# (b)(4).
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Manufacturer Narrative
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Investigation: the complaint investigation for false positive when using the bd max sars-cov-2 reagents (ref# 44500301) lot 0168224 was performed by the review of the manufacturing records, review of customer¿s data, and by the complaint¿s history review.Review of the manufacturing records of bd max sars-cov-2 reagents¿ indicated that the lot 0168224 was manufactured according to specifications and met performance requirements.Customer reported 3 false positives when using the bd sars-cov-2 kit on bd max with, at least, one known negative sample as negative control.Despite multiple attempts made to receive information from the customer, no data was provided for the investigation.Without available data, bd is unable to confirm the root cause.There is no indication of an increase in complaints for false positive results for the bd sars-cov-2 lot 0168224.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.
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Search Alerts/Recalls
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