Z-1580-2020 Class II Terminated
FDA device recall Z-1580-2020 was initiated by Abbott Gmbh & Co. KG on January 24, 2020 and is designated Class II. Reason for recall: Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier. The recall status is terminated (terminated August 8, 2023). Affected quantity: 2676 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- January 24, 2020
- Termination Date
- August 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2676 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, ID, IL, LA, MA, MD, ME, MI, MN, MC, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and countries of Albania, Argentina, Australia, Austria, Bahrain, Bangledesh, Belgium, Bermuda, Bosnia, Botswana, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Madagascar, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago Turkey, UEA, UK, Ukraine, Uruguay, Vietnam.