FDA Medical devices recall · December 24, 2025

Alinity ci-series System Control Module (SCM) recall

Read the official FDA notice ↗

Product

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI: 00380740137410. GTIN: 06952999490048. Software versions 3.6.1 and lower. Serial Numbers: SCM01010 SCM01012 SCM01016 SCM01035 SCM01043 SCM01051 SCM01063 SCM01069 SCM01075 SCM01076 SCM01078 SCM01082 SCM01085 SCM01086 SCM01087 SCM01088 SCM01092 SCM01093 SCM01094 SCM01095 SCM01098 SCM01099 SCM01101 SCM01102 SCM01106 SCM01107 SCM01110 SCM01115 SCM01116 SCM01120 SCM01121 SCM01122 SCM01123 SCM01124 SCM01126 SCM01127 SCM01128 SCM01129 SCM01132 SCM01134 SCM01135 SCM01136 SCM01137 SCM01138 SCM01142 SCM01143 SCM01149 SCM01150 SCM01151 SCM01154 SCM01163 SCM01166 SCM01170 SCM01171 SCM01172 SCM01174 SCM01175 SCM01176 SCM01179 SCM01180 SCM01181 SCM01184 SCM01192 SCM01193 SCM01194 SCM01196 SCM01197 SCM01198 SCM01199 SCM01200 SCM01201 SCM01203 SCM01204 SCM01205 SCM01207 SCM01211 SCM01213 SCM01216 SCM01217 SCM01219 SCM01220 SCM01221 SCM01222 SCM01223 SCM01224 SCM01225 SCM01226 SCM01229 SCM01230 SCM01232 SCM01236 SCM01237 SCM01238 SCM01239 SCM01240 SCM01244 SCM01247 SCM01249 SCM01251 SCM01252 SCM01253 SCM01254 SCM01255 SCM01256 SCM01257 SCM01258 SCM01267 SCM01268 SCM01269 SCM01270 SCM01271 SCM01273 SCM01274 SCM01277 SCM01279 SCM01281 SCM01282 SCM01283 SCM01284 SCM01286 SCM01289 SCM01290 SCM01291 SCM01293 SCM01294 SCM01297 SCM01298 SCM01300 SCM01301 SCM01302 SCM01305 SCM01306 SCM01307 SCM01308 SCM01310 SCM01312 SCM01313 SCM01314 SCM01315 SCM01316 SCM01317 SCM01320 SCM01321 SCM01323 SCM01326 SCM01328 SCM01333 SCM01334 SCM01335 SCM01336 SCM01337 SCM01338 SCM01339 SCM01340 SCM01341 SCM01342

Distribution

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

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0961-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.