ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19; MOLECULAR IVD FOR ID NOW COVID-19
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Catalog Number 190-000 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.Related reports: (b)(4).
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Event Description
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The customer reported six false positive results with the id now covid-19 assay on a id now instrument.Technical services (ts) inquired further on the details surrounding this allegation such as date of occurrence or patient identifiers, in which the customer did not provide any further information on this allegation.No adverse patient effects were reported.No additional patient information, including treatment and outcome, was provided.This manufacturer report addresses false positive result 1 of 6.
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Search Alerts/Recalls
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