REF: 08P4377 — Class II medical device recall Z-1456-2022

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-1456-2022`
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	64 units
Reason classes	potency
UPC / GTIN / UDI-DI	`00380740174989`
Lot numbers	`59801UQ04`, `60763UQ09`
Model numbers	`08P4377`

Product

REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 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-1456-2022. 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.