Catalog Number 256040 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that while using the kit grp a strep 30 test veritor, it gave a false positive result.There was no report of patient impact.Report 2 of 2.
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Event Description
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It was reported that while using the kit grp a strep 30 test veritor, it gave a false positive result.Patient was treated with antibiotics.Report 2 of 2.
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Manufacturer Narrative
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The following fields were updated with corrected and/or additional information: b1.Type of report: adverse event and product problem.B2.Other: change in treatment.B5.It was reported that while using the kit grp a strep 30 test veritor, it gave a false positive result.Patient was treated with antibiotics.Report 2 of 2.H1.Type of reportable event: serious injury.
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Search Alerts/Recalls
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