The customer reported three (3) false positive results with the binax now covid-19 ag card for multiple patients performed on various days.This mfr.Report addresses report two (2) of three (3).The customer reported a confirmed false positive result with the binax now covid-19 ag card performed on (b)(6).2023 using kit nasal swab.Confirmation testing via molecular (platform - (b)(6).By quidel) was performed on (b)(6).2023 which generated a negative result using utm swab.The customer reported that one of the patient was rsv positive.No additional patient information, including treatment and outcome, was provided.
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D4 udi : (b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 227446y 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 195-000/ lot 227446y, test base part number 195-430h/ lot 223594.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 227446y showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, storage conditions of the test cards, interpretation of the result, or the specific patient sample.G2 - report source h3 other text : single-use, device discarded.
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The customer reported three (3) false positive results with the binax now covid-19 ag card for multiple patients performed on various days.This mfr.Report addresses report two (2) of three (3).The customer reported a confirmed false positive result with the binax now covid-19 ag card performed on (b)(6) 2023 using kit nasal swab.Confirmation testing via molecular (platform - sofia fia by quidel) was performed on (b)(6) 2023 which generated a negative result using utm swab.The customer reported that one of the patient was rsv positive.No additional patient information, including treatment and outcome, was provided.
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