Home / Recalls / Medical Devices
Abbott Laboratories, Inc recalls Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Recalled November 5, 2014 · FDA recall Z-0131-2015 · Abbott Laboratories
Hazard
Package inserts have incorrect SmartWash parameters for Triglyceride. · FDA Class II
Units
11916 units
Sold at
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.
Description
Package inserts have incorrect SmartWash parameters for Triglyceride.
Product
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Manufacturer(s)
Abbott Laboratories, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →