Catalog Number 191-000 |
Device Problems
False Positive Result (1227); Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.Reference mfr no 1221359-2022-04837 through 1221359-2022-04844.
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Event Description
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The customer reported nine (9) false/unexpected results with the id now covid-19 instrument for multiple patient samples performed on unknown dates as part of validation studies.This mfr.Report addresses false result one (1) of nine (9).The customer reported a false/unexpected result with the id now covid-19 instrument performed on unknown dates on a patient sample.Although requested, no additional information was provided.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the investigation conclusion and corrections to b5, h6 "medical device problem code".The required intake information to enable further investigation, such as the kit's lot number and logfiles, 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.Please see related mfr report numbers: 1221359-2022-04837 through 1221359-2022-04844.
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Event Description
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The customer reported nine (9) false/unexpected results with the id now covid-19 instrument for multiple patient samples performed on unknown dates.This mfr.Report addresses test result one (1) of nine (9).The customer reported a false positive result with the id now covid-19 instrument performed on unknown dates on an unknown sample type.Pcr confirmation testing was performed with aus diagnostics platform and generated a negative result.Although requested, no additional information was provided.
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Manufacturer Narrative
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This report is being submitted to provide addtional information to the investigation completion.Per (b)(4), the customer performed the id now covid-19 positive neqas swab as a qc test and received a failing result.Per the investigation, this is the expected / intended result for the positive control swab as it is coated with covid-19 virus instead of inactivated influenza a and b viruses in the abbott control.There has been no malfunction of the assay.
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Search Alerts/Recalls
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