ARCHITECT c4000 REF 02P24-01/2P24 — Class II medical device recall Z-0272-2022
Ongoing recall by Abbott Laboratories, reported 2021-12-01, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include
| Recall number | Z-0272-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Irving, TX, United States |
| Recall initiated | 2021-09-29 |
| Classified | 2021-11-19 |
| Reported by FDA | 2021-12-01 |
| Distributed | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AF, AR, AT, AU, BB, BD, BE, BG, BH, BM, BO, BR, BS, BZ, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HT, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 7,535 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00380740003746, 00380740005924 |
| Serial numbers | C1600014, C1600015, C1600016, C1600017, C1600024, C1600025, C1600026, C1600027, C1600028, C1600029, C1600030, C1600031, C1600032, C1600033, C1600034, C1600035, C1600036, C1600037, C1600038, C1600040, C1600041, C1600042, C1600043, C1600044, C1600045 and 475 more |
| Model numbers | 01G06-11/1G06, 02P24-01/2P24, 03L77-01/3L77, 1P86, 1R24, 1R25 |
Product
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0272-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.