Open, Classified

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

FDA Recall Z-0961-2026 · Posted 2025-12-18

Recall StatusOpen, Classified

Product CodeJJE

Date Initiated2025-11-13

Product Quantity11653

Reason for Recall

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

Firm Action

On 11/13/2025, "Urgent Field Safety Notice Product Correction" notices were sent to customers who were asked to take the following actions: 1) Perform the Weekly maintenance procedures (i-series) 2630 Manual Wash Cup Cleaning (i-series) per Section 9 of the Alinity ci-series Operations Manual. 2) Field Service Representative will contact you to schedule installation of software version 3.7.0. 3) It is recommended to perform the Pipettor diagnostic procedures (c-series) 4109 Probe Alignment Test (c-series) daily for R1 and R2 pipettor probes per Section 9 of the Alinity ci-series Operations Manual until software version 3.7.0 is installed. 4) If you observe a bent pipettor probe (R1, R2), perform the component replacement procedure, Replace the reagent probes (c-series) per Section 9 of the Alinity ci-series Operations Manual. If you have forwarded the product to other laboratories, please inform them of this product correction and provide to them a copy of this letter. If you have questions regarding this information, contact Customer Service at 1-877-4ABBOTT.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR; and OUS (foreign) to countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, 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, Georgia, Germany, Greece, Greenland, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Montenegro, Morocco, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Tunisia, Turkey, UAE, Uganda, Ukraine, United Kingdom, Uruguay, Vietnam and Zambia. OUS: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, 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, GEORGIA, GERMANY, GREECE, GREENLAND, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOSOVO, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAWI, MALAYSIA, MALDIVES, MALTA, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORTHERN IRELAND, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA (CIS), RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VIETNAM, ZAMBIA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories · 2017-10-23 K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott Laboratories · 2017-10-19

Official Source

View FDA Recall →

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