Catalog Number 195-160 |
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 03/20/2024 |
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 or upon receipt of new information.
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Event Description
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Wife reported a false negative result on behalf of the consumer with the binaxnow covid-19 ag self test performed on (b)(6) 2024 with a nasal sample.No confirmation testing was performed.The consumer had symptoms such as coughing, new loss of taste and body aches.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 227505 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 195-160/ lot 227505, test base part number 195-430h/ lot 223646.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 227505 showed that the complaint rate is 0.000986%.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.
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Event Description
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Wife reported a false negative result on behalf of the consumer with the binaxnow covid-19 ag self test performed on (b)(6) 2024 with a nasal sample.No confirmation testing was performed.The consumer had symptoms such as coughing, new loss of taste and body aches.No additional patient information, including treatment and outcome, was provided.
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Search Alerts/Recalls
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