Recall record at a glance
| Official record | Z-0271-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Abbott Laboratories |
| Report date | Dec 1, 2021 |
| Recall initiation date | Sep 29, 2021 |
| Quantity | 20,994 systems |
| Location | Irving, TX, United States |
Official product description
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Why the product was recalled
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.
Distribution information
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,
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.