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 Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213565 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 213565, test base part number 10732998/ lot 208366.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213565 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, a possible assignable root cause is sample interference or cross contamination.H3 other text : device discarded; single-use device.
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Event Description
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The customer reported three (3) false negative results with the alere determine hiv 1/2 ag/ab for multiple tests performed from 11mar2023 to 13mar2023.This mfr.Report addresses test three (3) of three (3).The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.Repeat testing was performed on (b)(6) 2023 and generated negative results.Confirmatory testing was sent to quest diagnostics on (b)(6) 2023 to confirm hiv results.Results are unknown.Additional testing with siemens atellica (reactive combo) hiv was performed on (b)(6) 2023 and (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
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Manufacturer Narrative
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Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 213565 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 213565, test base part number 10732998/ lot 208366.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 213565 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.H10 h3 other text : device discarded; single-use device.
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Event Description
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The customer reported three (3) false negative results with the alere determine hiv 1/2 ag/ab for multiple tests performed from (b)(6) 2023 to (b)(6) 2023.This mfr.Report addresses test three (3) of three (3).The customer reported a false negative result with alere determine hiv 1/2 ag/ab performed on (b)(6) 2023.Repeat testing was performed on (b)(6) 2023 and (b)(6) 2023 and generated negative results.Confirmatory testing was sent to quest diagnostics on (b)(6) 2023 to confirm hiv results.Results are unknown.Additional testing with siemens atellica (reactive combo) hiv was performed on (b)(6) 2023 and (b)(6) 2023 which generated positive results.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
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