Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 102774 with the following internal whole blood and serum/plasma control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 102774 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) related to lot number 102774 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics (b)(4), inc.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.
|
This report represents the twelfth of 15 antibody (ab) (b)(6) alere determine hiv 1/2 ag/ab combo patient results reported by a customer to an abbott sales representative.Confirmatory testing was (b)(6) on a 4th generation hiv test (not otherwise specified).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.
|