Class 2 Device Recall Alinity ciseries System Control Module

• Date Initiated by Firm: May 30, 2023
• Date Posted: December 22, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0613-2024
• Recall Event ID: 93483
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Alinity ci-series System Control Module, REF: 03R70-01
• Code Information: UDI-DI: 00380740137410. Software Version 3.4.0 and lower.
• Recalling Firm/ Manufacturer: Abbott Laboratories; 1915 Hurd Dr; Irving TX 75038-4313
• For Additional Information Contact: 972-518-6000
• Manufacturer Reason for Recall: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
• FDA Determined Cause: Software design
• Action: On 5/30/23, correction notices were mailed to customers: -If code 5819 occurs, remove cartridges and onboard vial rack. Discard all cartridges and all samples in the onboard vial racks impacted by this issue. If a cartridge or onboard vial rack has fallen over inside the reagent carousel, contact Customer Service to clean any potential spill. -Avoid printing the Sample Laboratory report from the Sample Status Screen. If the Sample Laboratory report is printed verify the correct SID is printed on all pages. -When the barcode on the calibrator carton is scanned, only the master lot number and the expiration date are updated. The calibrator values remain from the previously configured master lot. To configure a new master lot for calibrators that have lot-specific calibrator values, the supervisor must verify that the correct values are entered and must edit them if necessary, or the supervisor must configure the master lot by importing the calibrator data. - Do not create a user defined assay with more than 40 Cuvette SmartWashes or 40 total reagent probe R1 and R2 SmartWashes. NOTE: The All setting can be used to replace individual reagent probe R1 or reagent probe R2 SmartWashes. Reagent probe settings that use the All setting need to be configured last. -Confirm for each user-defined assay that the sum of the configured sample volume + diluent volume + water volume is both greater than or equal to 80 micro L and less than or equal to 360 micro L -The label stock must meet the guidelines in 1D reagent barcode label requirements (c-series) in Section 4 of the Alinity ci-series Operations Manual and be compatible with Avery label templates 5520, L4773, or L7060. -If the ICT module status is exceeded with more than 20,000 samples processed, then confirm the expiration date of the ICT module before performing ICT assay testing. Complete and return the response form Questions can be directed to Customer Service at 1-877-4ABBOTT
• Quantity in Commerce: 8,424
• Distribution: US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BERMUDA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, BURKINA FASO, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FAROE ISLANDS, FINLAND, FRANCE, , GAZA & JERICHO,GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LITHUANIA, MACEDONIA, MADAGASCAR, MALAYSIA, MALDIVES, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UK, UKRAINE, URUGUAY, VIETNAM, ZAMBIA
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.