Lower risk Medical device recall · FDA · Published May 22, 2019

Abbott HbA1c Calibrators May Cause Test Errors - Recall for Incorrect Manufacturing

Abbott recalls HbA1c calibrators that may have incorrect manufacturing, risking inaccurate blood sugar test results outside a specific concentration range. Affected units may need replacement to ensure accurate diabetes monitoring.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1688-2020Medical device Abbott ›

Lower-risk recall

Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.

Take action

Contact the company

Recalling firmAbbott Laboratories1915 Hurd Dr · Irving, TX 75038

✎ GovInfoNow plain-language explainer

Abbott is recalling HbA:1c calibrators that could produce inaccurate blood sugar test results for some patients. This affects people using these calibrators with their diabetes testing devices, potentially leading to incorrect health decisions. Read more at govinfonow.com/recall/67885-abbott-hba1c-calibrators-may-cause-test-errors-recall-for-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/67885-abbott-hba1c-calibrators-may-cause-test-errors-recall-for-incorrect · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1688-2020

Cite this page

“Abbott HbA1c Calibrators May Cause Test Errors - Recall for Incorrect Manufacturing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67885-abbott-hba1c-calibrators-may-cause-test-errors-recall-for-incorrect. Based on FDA recall #Z-1688-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1688-2020%22&limit=1).

The FDA announced on May 22, 2019, that Abbott Laboratories is recalling Hemoglobin A1c Calibrators because a manufacturing defect in some calibrator level 2 bottles may cause biased patient test results. The firm is investigating the root cause of this Class II recall.

How to tell if you have it

Brand: Abbott
Product: HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R03 * S4P5X0 * FOR USE WITH ARCHITECT
List Number: 4P52-01
Lot Number: 54582UQ02
Quantity: 198 Kits

The hazard

The calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. While no impact to assay performance was observed between the HbA1c concentration range of 5.33% to 6.87%, a bias of greater than 3% may be seen with patient results outside of this range. This device failure can result in potentially negatively and positively biased patient test results for HbA1c.

Context

GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since May 14, 2012. Recent brand recalls include the November 13, 2025 Alinity ci-series System Control Module correction and the September 18, 2025 Alinity hq Analyzer Software Issue regarding incorrect results when saturation is present. Other recent recalls of similar products include the November 24, 2025 Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall for incorrect low glucose results and the June 8, 2026 Siemens Atellica CH A1c_E Test Recall for false HbA1c results risk.

How to tell if you have this one

Check for the model number 4P52-01 and lot number 54582UQ02 on the calibrator bottle. These calibrators are used with Abbott's Architect diabetes testing devices.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Calibrator Details
Look for the model number 4P52-01 and lot number 54582UQ02 on the calibrator bottle.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, FKL GA, IA, ID, IL, IN, KS, LA, MN, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, and WI; and countries of Austria, Germany, Italy, South Africa,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

May 22, 2019Firm started the recall
Apr 9, 2020FDA classified it Class II
Apr 15, 2020Published in FDA’s Enforcement Report
Jan 22, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67885-abbott-hba1c-calibrators-may-cause-test-errors-recall-for-incorrect">Abbott HbA1c Calibrators May Cause Test Errors - Recall for Incorrect Manufacturing (GovInfoNow)</a>

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-1688-2020 (May 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1688-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.