A customer reported (b)(6) results with the alere determine hiv-1/2 ag/ab combo test between (b)(6) 2019 and (b)(6) 2019.Confirmation testing with a 4th generation hiv test (not otherwise specified) was nonreactive for all six (6) patients.The sample type and specific result (antibody/antigen) was not reported.Patient gender, pregnancy status, treatment and patient outcome were not reported.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information were not successful.
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