Testing was performed at abbott diagnostics (b)(4).On retained kit lot 115273 with the following internal serum/plasma control samples: (b)(6) positive, (b)(6) positive, p24 positive, and (b)(6) negative.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 115273 were reviewed.This lot met the required release specifications.A review of the complaints reported as false positive or unconfirmed false positive related to lot number 115273 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).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.
|
A customer reported four (4) false positive results with alere determine (b)(6) ag/ab combo.This report represents two (2) of four (4).The customer reported a dual false positive antibody (ab)/antigen (ag) result on a serum sample with alere determine (b)(6) ag/ab combo.Confirmation testing (methodology: molecular viral load) was reported as negative/nonreactive.The patient gender, pregnancy status, treatment and outcome were unknown.The customer stated there was no death or serious injury based on the alere determine (b)(6) ag/ab combo result.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional patient information were not successful.
|