ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
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Catalog Number 195-000 |
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 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Reference mfr.Report: 1221359-2020-00467, 1221359-2020-00468, 1221359-2020-00469, 1221359-2020-00470, 1221359-2020-00472, 1221359-2020-00473, 1221359-2020-00474, 1221359-2020-00475 the current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is (b)(4).Based on the evidence available, it indicates that this device lot is performing within label claims.Investigation is not yet complete.Upon completion, abbott diagnostics (b)(4), inc.Will provide a supplemental report.
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Event Description
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A customer reported nine false negative results with the binaxnow covid-19 ag test.This report represents five of nine.The customer reported false negative results on a kitted swab with the binaxnow covid-19 ag test performed (b)(6) 2020.The nasal swab was used to swab both nostrils, as indicated per the product insert.Six drops of extraction reagent was added to the test well, the swab was inserted immediately into the test and rotated three (3) times clockwise, and the test was closed.After fifteen minutes, the test indicated negative results.Repeat testing was not performed.A specimen was collected immediately for confirmatory testing by pcr (not further specified).The results were positive (ct value not provided).The customer confirmed no death or serious injury based on the binaxnow covid-19 ag test results.The patient was symptomatic (not otherwise specified) at the time of testing.No treatment was provided to the patient.Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.Negative results do not rule out sars-cov-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with covid-19.Due to the risk of a false negative result potentially leading to no or delayed treatment, this event shall be considered reportable.
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Manufacturer Narrative
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Testing was performed at abbott diagnostics (b)(4) on retained kit lot 128566 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing batch records and quality control release testing for kit part number 195-000 / lot 128566 and test base part number 195-430h / lot 127440 were reviewed.This lot met the required release specifications.Abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue; however, it could possibly be related to the specific patient sample.
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