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Medical Monitoring Devices - Articles
FDA Failing to Monitor Safety of Medical Devices: Report
by
HealthFinder
Posted
Tue 02 Nov 2010 10:00am
TUESDAY, Nov. 2 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is not doing its job of properly monitoring the safety of medical devices, the authors of a new... said.
FDA spokeswoman Karen Riley said the agency is engaged in an ongoing effort to improve overall medical device safety monitoring. "We have an initiative underway
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Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5
by
FDA
Posted
Fri 18 Jun 2010 11:04am
DATE NOTIFICATION INITIATED:
June 8, 2010
PRODUCT / LOT NUMBER/EXPIRATION DATE:
COBAS AMPLICOR HIV MONITOR Test, v1.5
Lot Number... has confirmed that the HIV-1 MONITOR Quantitation Standard (HIM QS) vials in the COBAS AMPLICOR HIV-1 MONITOR Test, v1.5 generate low or no absorbance signals. This results
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