Testing was performed at abbott diagnostics (b)(6) on retained kit lots: 106477, 107755, 108399, 109469, 110100, 109895, 108250, and 108941 with the following internal whole blood and serum/plasma: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 106477, 107755, 108399, 109469, 110100, 109895, 108250, and 108941 were reviewed.These lots met the required release specifications.A review of the complaints reported as false positive related to the below lot numbers showed that the complaint rate is: kit lot:106477 - (b)(4).Kit lot 107755 - (b)(4).Kit lot 108399 - (b)(4).Kit lot 109469 - (b)(4).Kit lot 110100 - (b)(4).Kit lot 109895 - (b)(4).Kit lot 108250 - (b)(4).Kit lot 108941 - (b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(6) was unable to determine the exact root cause of the reported issue.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that this device lot is performing within labeled claims.
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A customer reported nine (9) (b)(6) results with the alere determine (b)(6) test.This report represents five (5) of the nine (9) (b)(6) (ag/ab not specified) alere determine (b)(6) patient results reported from a customer.Confirmation testing (methodology not otherwise specified) was (b)(6).The patient gender, pregnancy status, treatment and outcome were unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information were not successful.
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A customer reported nine (9) false positive results with the alere determine hiv-1/2 ag/ab combo test.No patient information was provided until 26 december 2019.This supplemental report represents five (5) of nine (9).A customer reported a dual false positive antibody (ab)/antigen (ag) result (sample type not otherwise specified) with the alere determine hiv 1/2 ag/ab combo.Confirmation testing with the abbott architect was negative/nonreactive.Patient gender, pregnancy status, treatment and outcome are unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information was not successful.Per the alere determine hiv-1/2 ag/ab combo product insert: a reactive result using alere determine hiv-1/2 ag/ab combo suggests the presence of hiv-1 p24 antigen and/or antibodies to hiv-1 and/or hiv-2 in the sample.The reactive result is interpreted as preliminary positive for hiv-1 p24 antigen and/or antibodies to hiv-1 and/orhiv-2.Alere determine hiv-1/2 ag/ab combo is intended as aid in the diagnosis of infection with hiv-1/2.Reactive test results should be confirmed by additional testing using other tests.
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