ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DETERMINE HIV - 1/2 AG/AB COMBO; IVD FOR HIV 1/2 AG/AB
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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 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.
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Event Description
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The customer reported multiple unconfirmed false positive results with the determine hiv 1/2 ag/ab combo.No additional patient information, including treatment and outcome, was available/confirmed.Per the customer, he does not "think" any of the patients were pregnant.
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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 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.
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Search Alerts/Recalls
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