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Terminated

Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

FDA Recall Z-1316-2019 · Posted None

Recalling FirmAbbott Gmbh & Co. KG
Recall StatusTerminated
Product CodeJJE
Date Initiated2019-03-07
Date Terminated2025-02-19
Product Quantity1557

Reason for Recall

Potential performance issues in the Alinity-ci software version 2.5.1

Firm Action

On March 7, 2019 Abbott issued the attached Product Correction letters to all installed Alinity ci series instrument customers: 1. Softwarerelated actions: Your Abbott representative will schedule a mandatory upgrade of your Alinity ciseries to software version 2.6.0 to resolve each of these issues. Refer to Appendix A for necessary actions required until software version 2.6.0 can be installed. Software version 2.6.0 also provides enhancements and additional changes to increase the usability of your system. If you require additional information, please contact Abbott Customer Service. 2. The Alinity ciseries Operations Manual distributed with software version 2.6.0 requires supplemental instructions for the following message: Message code 3696 The sample probe is not washed after aspirating a whole blood or red blood cell sample. If message code 3696 occurs, perform the following: a. Perform Asneeded Maintenance procedure 5906 Clean Sample and Reagent Probes (cseries) to clean the sample probe unless one of the following actions occurred before the initiation of assay processing: " The sample probe was replaced. " Daily maintenance procedure 5501 Daily Maintenance (cseries) was performed. b. Additional messages that are associated with this message can be used to determine the appropriate corrective action. Perform View additional messages that are associated with a message in the Alinity ciseries Operations Manual. 3. Bulk Solution Level Sensor related actions (refer to Appendix B for additional information): a. If LN 04S6801 Level Sensor, Bulk Solution is installed in the Alinity i Trigger or PreTrigger bulk solution reservoirs, Abbott recommends these sensors be replaced with a Level Sensor, Bulk Solution, LN 04S6802 before further test processing is performed. b. Abbott recommends all LN 04S6801 Level Sensor, Bulk Solution installed in the following bulk solution reservoirs be replaced with a Level Sensor, Bulk Solution, LN 04

Root Cause

Under Investigation by firm

Distribution Pattern

AR, AZ, CA, FL, GA, IL, MA, ME, MN, MO, NY, OK, SC, TN, TX, UT, VA, WI, and Puerto Rico ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, MADAGASCAR, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, and VIETNAM.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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