ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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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 09/13/2023 |
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 unknown date.Per the consumer, the first test taken generated a positive result and the second test conducted and generated 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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D4: udi: (b)(4).B3: date of event provided in section b3 is an approximation, was not provided by consumer.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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D4 udi - (b)(4).B3: date of event provided in section b3 is an approximation, was not provided by consumer.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 226583 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 226583, test base part number 195-430wl / lot 223604r.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 226583 showed that the complaint rate is (b)(4) respectively.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue of conflicting results, however it could have possibly been related to the specific patient sample.H3 other text : single-use, device discarded.
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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 unknown date.Per the consumer, the first test taken generated a positive result and the second test conducted and generated negative result.Confirmation testing was not performed.No additional patient information, including treatment and outcome, was provided.
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