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.Abbott diagnostics (b)(4).Was unable to determine the exact root cause of the reported issue.Attempts to gain additional information were not successful.
|
A customer reported a (b)(6) (ag/ab not specified) result with the alere determine hiv-1/2 ag/ab combo test.Confirmation testing was not reported.The patient gender, sample type, pregnancy status, treatment and outcome are unknown.There is insufficient information to determine if a malfunction occurred.Multiple attempts to gain additional information were not successful.
|