FDA-Device2014-11-05Class II
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Abbott Laboratories, Inc
Hazard
Package inserts have incorrect SmartWash parameters for Triglyceride.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Dominican Republic, Egypt, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turks and Caicos, Turkey, Uganda, United Arab Emirates, United Kingdom, and Uruguay.
Affected count
11916 units
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2015Don't want to check this manually?
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