Testing was performed at alere (b)(4) on retained kit lots 103698 and 107842 (exp 21 july 2020) with the following internal serum/plasma control samples: (b)(6) samples.All test results were valid and performed as expected.Additionally, the manufacturing batch records for lots 103698 and 107842 were reviewed.This lot met the required release specifications.A review of the complaints reported as (b)(6) or unconfirmed (b)(6) related to lot numbers 103698 and 107842 showed that the complaint rate is (b)(4), respectively.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 the device lots are performing within labeled claims.
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