Testing was performed at alere (b)(4) on retained kit lot 101802 with the following internal serum plasma control samples: (b)(6).All test results were valid and performed as expected.Additionally, the manufacturing batch records for lot 101802 were reviewed.This lot met the required release specifications.A review of the complaints reported (b)(6) related to lot number 101802 showed that the complaint rate is (b)(4).The evidence available does not indicate that the product is performing outside label claims.Alere (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.
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