Catalog Number 20377 |
Device Problems
False Negative Result (1225); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: to be determined.Root cause: to be determined.Source: email.Additional information will be included in a follow-up report upon completion of the investigation.
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Event Description
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Customer reporting false negative flu b results on 8 symptomatic patients out of 180 patients tested.Customer states the results were positive by pcr.Report 1 of 8.
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Manufacturer Narrative
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Updates made: b4; date of report ; updated to today's date.H6; type of investigation codes ; investigation findings codes ; investigation conclusion codes.Investigation summary: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends for the reported issue for this lot.Tested 3x customer returned devices with flu a positive standard and 3x retained devices with flu b positive standard.All devices yielded valid and accurate results at the 15 minute result read time.Root cause:can not determine with customer return kit testing.Source: email.
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Search Alerts/Recalls
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