Model Number 256040 |
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 01/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 that while using kit grp a strep 30 test veritor a false negative result was obtained by the laboratory personnel.A false negative may lead to the misdiagnosis of a certain infectious condition and therefore delayed treatment.There was no report of patient impact.
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Manufacturer Narrative
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H6: investigation summary: this statement summarizes the investigation results regarding your complaints that alleges false negative or discrepant results when using kit grp a strep 30 test veritor (material # 256040), batch number 9303075.Bd quality performs a systematic approach to investigate false negative complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.Investigation and testing were performed on the batch numbers provided.The complaint was unable to be confirmed.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.
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Event Description
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It was reported that while using kit grp a strep 30 test veritor a false negative result was obtained by the laboratory personnel.A false negative may lead to the misdiagnosis of a certain infectious condition and therefore delayed treatment.There was no report of patient impact.
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Search Alerts/Recalls
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