The required information to enable further investigation, such as the kit's lot number and patient's medical history, was not available and therefore a root cause investigation was not performed.A review of complaints' trend reveal that all of the alere determine hiv 1/2 ag/ab combo batches are performing according to label claims.The exact root cause of the reported issue could not be determined.Attempts to gain additional information were not successful.
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A customer reported a (b)(6) result on the alere determine hiv-1/2 ag/ab combo test.The sample type was not reported.The customer stated that confirmatory testing on an abbott architect did not produce any results.Additional confirmatory testing (hiv test not otherwise specified) at the public health lab produced (b)(6) results.The 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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