Abbott Alinity c Hemoglobin Reagent Kit Recall: False High A1c Results Risk
Abbott recalls Alinity c Hemoglobin Reagent Kit (REF: 08P4377) due to potential false high A1c results. Affected units include specific lot numbers and sizes. Consumers should contact Abbott for details.
Lower-risk 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.
Contact the company
What happened, in plain English
Abbott is recalling Alinity c Hemoglobin Reagent Kits that could produce false high A1c results. This may lead to incorrect diabetes management decisions if used in blood tests. Read more at govinfonow.com/recall/60518-abbott-alinity-c-hemoglobin-reagent-kit-recall-false-high-a1c.
Source Summary by GovInfoNow · govinfonow.com/recall/60518-abbott-alinity-c-hemoglobin-reagent-kit-recall-false-high-a1c · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1456-2022
Cite this page
“Abbott Alinity c Hemoglobin Reagent Kit Recall: False High A1c Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60518-abbott-alinity-c-hemoglobin-reagent-kit-recall-false-high-a1c. Based on FDA recall #Z-1456-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2022%22&limit=1).
Why it’s dangerous
The reagent kit can generate falsely elevated A1c results when used with Abbott's ARCHITECT or Alinity c hemoglobin A1c assays. This could lead to incorrect diabetes management decisions if the false high results are acted on.
Who’s affected
People using the Alinity c Hemoglobin Reagent Kit for blood tests may be affected. Those with diabetes who rely on A1c test results are at higher risk.
How to tell if you have this one
Check for the reagent kit with lot numbers 59801UQ04 or 60763UQ09. The kit includes specific sizes: R1 (5 x 46.0 mL), R2 (5 x 18.3 mL), and A1cDL (5 x 67.6 mL).
- Brand
Abbott- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US: 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 OUS: ALBANIA ALGERIA ANDORRA ANGOLA ARGENTINA ARMENIA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BANGLADESH BELARUS BELGIUM BERMUDA BOSNIA AND HERZEGOVI BRAZIL BRUNEI BULGARIA BURKINA FASO CANADA CHILE CHINA COLOMBIA COSTA RICA Country CROATIA CYPRUS CZECH REPUBLIC ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FAROE ISLANDS FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAMAICA JORDAN KAZAKHSTAN KENYA KUWAIT KYRGYZSTAN LEBANON LIBYA LITHUANIA MACEDONIA MALAYSIA MALDIVES MALI MEXICO MOLDOVA MOROCCO MOZAMBIQUE NAMIBIA NETHERLANDS NIGERIA NORWAY OMAN PAKISTAN PALESTINIAN TERRITOR PANAMA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL QATAR REPUBLIC OF KOSOVO REPUBLIC OF YEMEN ROMANIA RUSSIA RWANDA SAUDI ARABIA SENEGAL SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SPAIN ST. LUCIA ST. VINCENT SWEDEN SWITZERLAND TANZANIA THAILAND THE GAMBIA TRINIDAD & TOBAGO TUNISIA TURKEY TURKS & CAICOS UAE UGANDA UNITED KINGDOM URUGUAY UZBEKISTAN VIETNAM ZIMBABWE
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1454-2022 | 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; UDI/DI: 00380740102746/ Lots: 59588UQ04, 59868UQ05, 59900UQ06, 60138UQ07, 60237UQ08, 60535UQ08, 60698UQ09, 60880UQ10, 61066UQ11, 61246UQ01, 61250UQ01 | 103,316 |
| Z-1455-2022 | REF: 08P4320, 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; UDI/DI: 00380740135591/ Lots: 59561UQ04, 59779UQ05, 60229UQ07, 60540UQ09, 61011UQ10, 61349UQ01, 61658UQ01 | 7,391 units |
| Z-1456-2022 | 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; UDI/DI: 00380740174989/ Lots: 59801UQ04 and 60763UQ09 | 64 units |
What to do — step by step
Contact Abbott
Reach out to Abbott Laboratories for specific instructions on how to handle the recalled kit.
Where it went and when
Where it was distributed
Distributed in 42 states and Puerto Rico, and outside the U.S.
FDA distribution: “US: 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 OUS: ALBANIA ALGERIA ANDORRA ANGOLA ARGENTINA ARMENIA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BANGLADESH…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1456-2022 (June 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1456-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.