A customer reported four (4) patients with (b)(6) antigen (ag) and/or antibody (ab) results with the alere determine (b)(6) test.This report represents patient four (4) of four (4).The customer reported a (b)(6) result (ab/ag not otherwise specified) with the alere determine (b)(6) test.The sample type was not provided.Confirmation testing (methodology not otherwise specified) was (b)(6).Patient gender, pregnancy status, treatment and outcome are unknown.Attempts to gain additional information were not successful.There is insufficient information to determine if a malfunction occurred.
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