Z-1580-2020 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden, N/A

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

LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.

Reason for Recall

Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

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.

Code Information

LN 3R70-01; software version 2.6.2 and earlier.