Alinity ci-series System Control Module (SCM)
Medical device recall Z-0961-2026. Published in FDA’s Enforcement Report on Dec 24, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 24, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 52 states named
- 11653 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
11653, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 SCM01343 SCM01344 SCM01345 SCM01346 SCM01348 SCM01349 SCM01350 SCM01354 SCM01355 SCM01356 SCM01357 SCM01361 SCM01362 SCM01365 SCM01368 SCM01370 SCM01371 SCM01372 SCM01373 SCM01374 SCM01375 SCM01376 SCM01377 SCM01378 SCM01379 SCM01380 SCM01381 SCM01382 SCM01383 SCM01385 SCM01386 SCM01387 SCM01388 SCM01389 SCM01393 SCM01394 SCM01395 SCM01396 SCM01397 SCM01399 SCM01401 SCM01402 SCM01403 SCM01404 SCM01405 SCM01406 SCM01407 SCM01408 SCM01409 SCM01411 SCM01412 SCM01414 SCM01415 SCM01416 SCM01417…
FDA’s list runs to 104,976 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
52 states and territories.
Every one of them
- 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 FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 13, 2025.
- FDA classified it on Dec 18, 2025.
- FDA’s Enforcement Report published it on Dec 24, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Laboratories, of Irving, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 104,976 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.