Testing was performed at abbott diagnostics scarborough, inc.On retained kit lots: 106477, 107755, 108399, 109469, 110100, 109895, 108250, and 108941 with the following internal whole blood and serum/plasma: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 106477, 107755, 108399, 109469, 110100, 109895, 108250, and 108941 were reviewed.These lots met the required release specifications.A review of the complaints reported as false positive related to the below lot numbers 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 nine (9) (b)(6) results with the alere determine hiv-1/2 ag/ab combo test.This report represents six (6) of the nine (9) (b)(6) (ag/ab not specified) alere determine hiv 1/2 ag/ab combo patient results reported from a customer.Confirmation testing (methodology not otherwise specified) was negative/nonreactive.The patient gender, pregnancy status, treatment and outcome were unknown.There is insufficient information to determine if a malfunction occurred.Attempts to gain additional information were not successful.
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Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 101439 with the following internal s/p control samples: hiv-1 positive, hiv-2 positive, p24 positive, and hiv negative.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 101439 were reviewed.This lot met the required release specifications.(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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