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 09/06/2023 |
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 kit performed on (b)(6) 2023 on a nasal kitted swab.On (b)(6) 2023, the first test taken generated a positive result, and the second test, performed on the same day, generated a negative result.Additional testing was not performed.The consumer confirmed there was no patient harm due to the test results.Additionally, the consumer confirmed there was no delay or impact in the patient's treatment.
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Manufacturer Narrative
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D4-udi: (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 221367 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: 221367, test base part number 195-430h/ lot: 217455.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 221367 showed that the complaint rate is (b)(4), respectively.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to the specific patient sample.H3 other text : single use; device discarded.
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Search Alerts/Recalls
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