REF: 4P52-20 Hemoglobin A1c for use with Architect — Class II medical device recall Z-1454-2022
Ongoing recall by Abbott Laboratories, reported 2022-08-03, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the
| Recall number | Z-1454-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Irving, TX, United States |
| Recall initiated | 2022-06-09 |
| Classified | 2022-07-22 |
| Reported by FDA | 2022-08-03 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JM, JO, KE, KW, LB, LT, MA, MX, MY, NG, NL, NO, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, UY, VN, ZA |
| Quantity | 103,316 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00380740102746 |
| Lot numbers | 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, 61250UQ01 |
| Model numbers | 4P52-20 |
Product
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Reason for recall
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
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-1454-2022. 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.