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BRIEF-U.S. FDA releases statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​
2017年7月13日 / 下午3点25分 / 4 个月前

BRIEF-U.S. FDA releases statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​

July 13 (Reuters) - U.S. FDA:

* Statement from Alberto Gutierrez on status of FDA’s investigation into inaccurate results from certain lead tests‍​

* Says as part of investigation, we inspected Magellan Diagnostics’ facility in North Billerica, Massachusetts

* Says design validation for Magellan Diagnostics’ leadcare test systems did not ensure device conforms to defined user needs and intended uses‍​

* Report regarding leadcare test systems device correction, removal actions was not sent to FDA within 10 days of initiating correction or removal

* Says the design change implemented by Magellan Diagnostics to increase incubation time is inadequate

* MDR report was not submitted within 30 days of receiving information that suggests that marketed device has malfunctioned

* Reviewing evidence from Magellan Diagnostics’ facility inspection to determine if there have been violations of federal law Source text (bit.ly/2uVW6gu) Further company coverage:

我们的标准:汤森路透“信任原则”
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