Testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot 107755 with the following internal whole blood and serum/plasma 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 107755 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 107755 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.Abbott diagnostics scarborough, 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.
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A customer reported four (4) patients with false positive antigen (ag) and/or antibody (ab) results with the alere determine (b)(6) ag/ab combo test.This report represents patient three (3) of four (4).The customer reported a false positive result (ab/ag not otherwise specified) with the alere determine (b)(6) ag/ab combo test.The sample type was not provided.Confirmation testing (methodology not otherwise specified) was negative/nonreactive.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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