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.
- Recall Initiated
- January 24, 2020
- Terminated
- August 8, 2023
- Recall Number
- Z-1580-2020
- Quantity
- 2676 units
Reason for Recall
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Distribution
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.
Lot / Code Info
LN 3R70-01; software version 2.6.2 and earlier.
Root Cause
Software design
Action Taken
The firm initiated the recall letter on January 24, 2020. The "Product Correction, Urgent - Immediate Action Required" notice identified the correction of the Alinity ci-series Software version 2.6.2 and earlier due to potential performance issues. the notice informed that Abbott is releasing Alinity ci-series Software version 3.1.0 to correct the issues. The notice provided the necessary actions required to be performed until the mandatory upgrade to SW 3.1.0 is complete. The notice referenced that details are included in table1 below. the notice detail that an Abbott representative will schedule a mandatory upgrade of your Alinity ci-series to software version 3.1.0. The notice also informed the customer if you have forwarded the product listed above to other laboratories, please inform them of the Product Correction and provide them a copy of this letter. The notice further instructs the customer to please retain this letter for your laboratory records The notice instructed the customers to please Abbott's Customer Service at 1 877 4ABBOTT(available 24 hours a day, 7 days a week). For customers outside the U.S., to please contact your local area Customer Service.