Categories
rss

Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

Murilo Freitas - 16:00, 23 de April de 2025118
FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.

http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-results-certain-capillary-blood-collection-tubes-used-magellan-diagnostics

 
Categories
rss

FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I

Murilo Freitas - 04:00, 17 de April de 2025129
On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072

 
PRAIS 2.0