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 11/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The date provided is an estimate as the exact date of occurrence was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Single-use; device discarded.
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Event Description
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The customer reported an unknown quantity of false positive results with the determine hiv 1/2 ag/ab combo 25t performed on or before (b)(6) 2022.This mfr.Report is three (3) of four (4) and lot number 169496.The quantity of false results per lot number was not provided.Confirmation testing via pcr performed at a third-party lab (platform: unknown) generated negative results.Although requested, no additional information, including patient treatment and outcome, was provided.
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Event Description
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The customer reported an unknown quantity of false positive results with the determine hiv 1/2 ag/ab combo 25t performed on or before (b)(6) 2022.This mfr.Report is three (3) of four (4) and lot number 177935.The quantity of false results per lot number was not provided.The customer stated a blood sample was tested from a fingerstick.Confirmation testing via pcr performed at a third-party lab (platform: unknown) on an intravenous blood sample generated negative results.Although requested, no additional information, including patient treatment and outcome, was provided.
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Manufacturer Narrative
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Please see updates: b5, d4 (lot number) the date provided in b3 is an estimate as the exact date of occurrence was not provided.Further information was received from the customer, it was determined that those receiving a false positive result were either male or a non-pregnant female patient.As such, the risk of a serious adverse event is low and not likely to cause a death or serious injury.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single-use; device discarded.
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Manufacturer Narrative
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Additional information: d4 (exp date), h4.Investigation conclusion: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 177935 with positive quality control samples and internal negative quality control samples.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: 177935, device part number 10732998 / lot: 169496.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 177935 showed that the complaint rate is 0.0268%.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.
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Event Description
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The customer reported an unknown quantity of false positive results with the determine hiv 1/2 ag/ab combo 25t performed on or before 10nov2022.This mfr.Report is three (3) of four (4) and lot number 177935.The quantity of false results per lot number was not provided.The customer stated a blood sample was tested from a fingerstick.Confirmation testing via pcr performed at a third-party lab (platform: unknown) on an intravenous blood sample generated negative results.Although requested, no additional information, including patient treatment and outcome, was provided.
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Search Alerts/Recalls
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