(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was ma nufactured according to release specification.The manufacturing site reports "it is confirmed that a sample stuck in transit due to covid-19 lockdown announced in india since (b)(5) 2020 and is available for return.If in the event that the sample is delivered to the investigation site, the complaint will be reopened, and a sample investigation will be conducted.".
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