Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0961-2026

Abbott Laboratories recalls Alinity ci-series System Control Module (SCM)

Abbott LaboratoriesIrving, TX, United StatesReported Dec 24, 2025 · 8 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Alinity ci-series System Control Module (SCM), REF: 03R70-0103R70-20
    UDI-DI 00380740137410.GTIN 06952999490048.
    400 affected lots
    SCM01010SCM01012SCM01016SCM01035SCM01043SCM01051SCM01063SCM01069
    +392 moreSCM01075SCM01076SCM01078SCM01082SCM01085SCM01086SCM01087SCM01088SCM01092SCM01093SCM01094SCM01095SCM01098SCM01099SCM01101SCM01102SCM01106SCM01107SCM01110SCM01115SCM01116SCM01120SCM01121SCM01122SCM01123SCM01124SCM01126SCM01127SCM01128SCM01129SCM01132SCM01134SCM01135SCM01136SCM01137SCM01138SCM01142SCM01143SCM01149SCM01150SCM01151SCM01154SCM01163SCM01166SCM01170SCM01171SCM01172SCM01174SCM01175SCM01176SCM01179SCM01180SCM01181SCM01184SCM01192SCM01193SCM01194SCM01196SCM01197SCM01198SCM01199SCM01200SCM01201SCM01203SCM01204SCM01205SCM01207SCM01211SCM01213SCM01216SCM01217SCM01219SCM01220SCM01221SCM01222SCM01223SCM01224SCM01225SCM01226SCM01229SCM01230SCM01232SCM01236SCM01237SCM01238SCM01239SCM01240SCM01244SCM01247SCM01249SCM01251SCM01252SCM01253SCM01254SCM01255SCM01256SCM01257SCM01258SCM01267SCM01268SCM01269SCM01270SCM01271SCM01273SCM01274SCM01277SCM01279SCM01281SCM01282SCM01283SCM01284SCM01286SCM01289SCM01290SCM01291SCM01293SCM01294SCM01297SCM01298SCM01300SCM01301SCM01302SCM01305SCM01306SCM01307SCM01308SCM01310SCM01312SCM01313SCM01314SCM01315SCM01316SCM01317SCM01320SCM01321SCM01323SCM01326SCM01328SCM01333SCM01334SCM01335SCM01336SCM01337SCM01338SCM01339SCM01340SCM01341SCM01342SCM01343SCM01344SCM01345SCM01346SCM01348SCM01349SCM01350SCM01354SCM01355SCM01356SCM01357SCM01361SCM01362SCM01365SCM01368SCM01370SCM01371SCM01372SCM01373SCM01374SCM01375SCM01376SCM01377SCM01378SCM01379SCM01380SCM01381SCM01382SCM01383SCM01385SCM01386SCM01387SCM01388SCM01389SCM01393SCM01394SCM01395SCM01396SCM01397SCM01399SCM01401SCM01402SCM01403SCM01404SCM01405SCM01406SCM01407SCM01408SCM01409SCM01411SCM01412SCM01414SCM01415SCM01416SCM01417SCM01418SCM01421SCM01422SCM01423SCM01424SCM01425SCM01429SCM01430SCM01431SCM01432SCM01433SCM01434SCM01437SCM01438SCM01439SCM01440SCM01442SCM01443SCM01444SCM01445SCM01446SCM01447SCM01448SCM01449SCM01450SCM01451SCM01452SCM01453SCM01454SCM01455SCM01456SCM01457SCM01458SCM01460SCM01461SCM01462SCM01465SCM01466SCM01467SCM01468SCM01469SCM01470SCM01471SCM01473SCM01474SCM01475SCM01476SCM01478SCM01479SCM01480SCM01481SCM01483SCM01485SCM01486SCM01487SCM01489SCM01491SCM01492SCM01493SCM01494SCM01495SCM01496SCM01497SCM01499SCM01501SCM01503SCM01504SCM01505SCM01506SCM01508SCM01511SCM01512SCM01513SCM01515SCM01517SCM01518SCM01519SCM01524SCM01525SCM01526SCM01527SCM01528SCM01529SCM01530SCM01531SCM01532SCM01534SCM01535SCM01536SCM01539SCM01540SCM01542SCM01544SCM01545SCM01547SCM01548SCM01553SCM01556SCM01557SCM01558SCM01560SCM01561SCM01562SCM01563SCM01564SCM01566SCM01567SCM01568SCM01569SCM01570SCM01571SCM01572SCM01575SCM01576SCM01577SCM01579SCM01580SCM01581SCM01582SCM01584SCM01586SCM01587SCM01588SCM01589SCM01593SCM01594SCM01595SCM01597SCM01598SCM01599SCM01600SCM01601SCM01602SCM01603SCM01604SCM01605SCM01607SCM01608SCM01609SCM01610SCM01611SCM01613SCM01615SCM01616SCM01617SCM01618SCM01619SCM01620SCM01622SCM01623SCM01624SCM01625SCM01627SCM01630SCM01631SCM01632SCM01633SCM01634SCM01635SCM01636SCM01638SCM01641SCM01642SCM01645SCM01647SCM01648SCM01649SCM01650SCM01651SCM01652SCM01654SCM01655SCM01657SCM01659SCM01660SCM01661SCM01662SCM01665SCM01666SCM01668SCM01669SCM01670SCM01678SCM01680SCM01681SCM01682SCM01683SCM01684SCM01686

What the firm is doing

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.

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls