ARCHITECT c4000
Medical device recall Z-0272-2022. Published in FDA’s Enforcement Report on Dec 1, 2021.
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 1, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 50 states named in where it went
- 7,535 systems 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?
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
7,535 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Description/List Number ARCHITECT c4000 Module List Number: 2P24 UDI: (01)00380740003746(21)c4123456(240)02P2401 Serial Numbers: C400000 C400010 C400011 C400012 C400013 c400014 c400015 C400016 C400017 C400018 C400019 C400020…
Every code shown here, 1,993 characters
Product Description/List Number ARCHITECT c4000 Module List Number: 2P24 UDI: (01)00380740003746(21)c4123456(240)02P2401 Serial Numbers: C400000 C400010 C400011 C400012 C400013 c400014 c400015 C400016 C400017 C400018 C400019 C400020 C400023 C400024 C400025 C400026 C400027 C400030 C400031 C400032 C400034 C400035 C400036 C400038 C400039 C400040 C400041 C400042 C400043 C400045 C400046 C400047 C400049 C400050 C400051 C400053 C400054 C400055 C400056 C400057 C400058 C400060 C400061 C400062 C400063 C400064 C400065 c400066 C400067 C400068 C400069 C400070 C400071 C400072 C400073 C400074 C400075 C400077 C400078 C400079 C400080 C400081 C400083 C400084 C400085 C400086 C400087 C400089 C400090 C400091 C400092 C400093 C400095 C400096 C400098 C400099 C400100 C400101 C400102 C400104 C400105 C400106 C400107 C400108 C400109 C400112 C400114 C400115 C400116 C400117 C400118 C400119 C400120 C400121 C400122 C400123 C400124 C400125 C400127 C400129 C400132 C400133 C400134 C400135 C400136 C400137 c400139 C400140 C400141 C400142 C400143 C400144 C400145 C400146 C400147 C400148 C400149 C400150 C400151 C400152 C400153 C400154 C400155 C400156 C400157 C400158 C400159 C400160 C400161 C400162 C400163 C400164 C400165 C400166 C400167 C400168 C400169 C400170 C400171 C400172 C400173 C400174 C400175 C400176 C400177 C400178 C400179 C400182 C400183 C400184 C400185 C400186 C400187 C400188 C400189 C400190 C400191 C400192 C400195 C400196 C400197 C400199 C400200 C400201 C400202 C400203 C400204 C400205 C400206 C400207 C400209 C400210 C400211 C400212 C400213 C400214 C400215 C400217 C400218 C400220 C400222 C400223 C400224 C400227 c400228 C400229 C400230 C400231 C400232 C400234 C400235 C400236 C400237 C400238 C400239 C400240 C400241 C400242 C400243 C400244 C400245 C400246 C400247 C400248 C400250 C400251 C400252 C400253 C400254 C400256 C400258 C400259 C400260 C400261 C400262 C400263 C400264 C400266 C400268 C400269 C400270 C400271 C400273 C400274 C400275 C400276 C400277 C400278 c400279 C400280 C400281 C400282…
FDA’s list runs to 99,079 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.
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: AFGHANISTAN ALBANIA, ALGERIA, ANDORRA, ANGOLA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHAMAS, BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BELIZE, BENIN, BERMUDA, BOLIVIA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, BURKINA FASO, BURUNDI, CAMBODIA, CAMEROON, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEMOCRATIC REP. OF CONGO, DENMARK, FAROE ISLANDS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ERITREA, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GREENLAND, GUATEMALA, GUINEA, HAITI, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MADAGASCAR, MALAWI, MALAYSIA, MALDIVES, MALI, MALTA, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MONTSERRAT, MOROCCO, MOZAMBIQUE, MYANMAR, NAMIBIA, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, ST. LUCIA, ST. VINCENT, SURINAME, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURK & CAICOS, TURKEY, UAE, UGANDA, UK, UKRAINE, URUGUAY, UZBEKISTAN, VIETNAM, WEST BANK/GAZA STRIP, YEMEN, ZAMBIA, ZIMBABWE,
The states and territories these words name
50 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
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 29, 2021.
- FDA classified it on Nov 19, 2021.
- FDA’s Enforcement Report published it on Dec 1, 2021.
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.
- How the firm first told its customers: Letter.
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 99,079 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
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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.