ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T; TEST, HIV DETECTION
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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 Date 07/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Reference mfr number - 1221359-2022-04380.
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Event Description
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The customer reported two (2) false positive results with the determine hiv 1/2 ag/ab combo 25t for two patients performed on various dates.This mfr.Report addresses patient 1 of 2.The consumer reported a false positive result with the determine hiv 1/2 ag/ab combo 25t test on (b)(6) 2022.Confirmatory testing at lab corp was performed and generated a negative result, also customer confirmed patient was pregnant and test was performed before delivery.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 177515 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 7d2648 / lot 177515 and test base part number 10732998 / lot 169489.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 177515 showed that the complaint rate is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to the specific patient sample.
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