FDA-Device2015-07-01Class II
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Remel Inc
Hazard
Use of the recalled product may result in false positive reports.
Sold states
Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
Affected count
21 devices
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1842-2015Don't want to check this manually?
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