Catalog Number 7D2648 |
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 09/01/2022 |
Event Type
malfunction
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Event Description
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The consumer reported two false positive results with the determine hiv 1/2 ag/ab combo performed on unknown date.This mfr report addresses test two (2) of two (2).The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on unknown date and type of sample.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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The date of event provided in this section was an approximation, it was not provided by customer.The investigation is still in progress.A supplemental report will be provided after completion.
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Event Description
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The consumer reported two false positive results with the determine hiv 1/2 ag/ab combo performed on unknown date.This mfr.Report addresses test two (2) of two (2).The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on unknown date and type of sample.No additional patient information, including treatment and outcome, was provided.
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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.D1 brand name; e3 occupation h3 other text : device discarded, single use device.
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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.Incorrect date was inadvertently reported on supplemental 1- in g3 as 28sep2022, it should be 07nov2022.H3 other text : device discarded, single use device.
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Event Description
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The consumer reported two false positive results with the determine hiv 1/2 ag/ab combo performed on unknown date.This mfr.Report addresses test two (2) of two (2).The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo performed on unknown date and type of sample.No additional patient information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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