Catalog Number 195-160 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2024 |
Event Type
malfunction
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Event Description
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The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6) 2024.Per the consumer, the first test taken generated a positive result and the second test conducted and generated a negative result.Confirmation testing was not performed.No additional patient information, including treatment and outcome, was provided.
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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.H3 other text : device discarded; single-use device.
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Event Description
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The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on (b)(6)2024.Per the consumer, the first test taken generated a positive result and the consumer conducted two (2) more tests on the same day, and both generated a negative result.Confirmation testing was not performed.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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Additional information:- new information was received on 22feb2024 and b5 was updated accordingly.The intake information required to enable further investigation, such as the kit¿s lot number, was not provided and an investigation was not able to be performed.A product deficiency could not be determined.Notwithstanding, complaints against these trend codes are monitored to identify and track any out of trend / unexpected performance at the lot and product family level.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : device discarded; single-use device.
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Search Alerts/Recalls
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