Class 2 Device Recall Alinity ciseries System Control Modul; LN 3R7001e e (SCM)

• Date Initiated by Firm: January 24, 2020
• Create Date: March 26, 2020
• Recall Status: Terminated on August 08, 2023
• Recall Number: Z-1580-2020
• Recall Event ID: 84831
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: 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.
• Code Information: LN 3R70-01; software version 2.6.2 and earlier.
• Recalling Firm/ Manufacturer: Abbott Gmbh & Co. KG; Max-Planck-Ring 2; 65205; Wiesbaden Germany
• For Additional Information Contact: Albert Chianello; 224-668-1923
• Manufacturer Reason for Recall: Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 2676 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.