Lower risk Medical device recall · FDA · Published December 9, 2022

Abbott Alinity m System Recall: Calibration Errors May Cause Misconfiguration

Abbott recalls Alinity m System devices with potential calibration errors that could misconfigure testing results. Affected units may need recalibration or correction.

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

🇺🇸 FDA recall #Z-1009-2023Medical device Abbott ›

Lower-risk recall

The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.

Take action

Contact the company

Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315

✎ GovInfoNow plain-language explainer

Abbott is recalling Alinity m System devices that may have calibration errors causing misconfigured testing results. This could lead to inaccurate nucleic acid test outcomes if the system is used without correction. Read more at govinfonow.com/recall/59181-abbott-alinity-m-system-recall-calibration-errors-may-cause-misconfiguration.

Source Summary by GovInfoNow · govinfonow.com/recall/59181-abbott-alinity-m-system-recall-calibration-errors-may-cause-misconfiguration · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1009-2023

Cite this page

“Abbott Alinity m System Recall: Calibration Errors May Cause Misconfiguration.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59181-abbott-alinity-m-system-recall-calibration-errors-may-cause-misconfiguration. Based on FDA recall #Z-1009-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1009-2023%22&limit=1).

The FDA announced on 2022-12-09 that Abbott Molecular, Inc. is recalling the Alinity m System due to potential calibration misconfigurations. Owners should contact the company for remedy details.

How to tell if you have it

Brand: Abbott
Product: Alinity m System
Model Number: 08N53-002

The hazard

The FDA said the firm identified three potential issues impacting ADUs installed on distributed systems. These include incorrect board values referencing calibration data, inability to recognize specific error handling during calibration, and incorrect configurations from manufacturing conditions.

Context

GovInfoNow's records show Abbott Molecular, Inc. has 19 other recalls on record since 2021-08-04. Other recent recalls of similar products include Abbott Alinity m Resp-4-Plex AMP Kit Recall (2025-04-28), Abbott Alinity m System Recall (2025-03-20), and Abbott Alinity m HPV Kit Recall (2024-09-12). Other recent recalls of similar products include Roche cobas pro integrated solutions recall (2026-01-20), Medline Convenience Kits Recall (2026-01-07), and Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (2025-12-11).

How to tell if you have this one

Check for model number 08N53-002 on the Alinity m System. The recall applies to devices sold with this specific model number.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Calibration Status
Verify if the system has been serviced or if calibration errors were detected.

How this recall unfolded

Recall timeline

FDA published this recall 54 days after the firm started it.

Dec 9, 2022Firm started the recall
Jan 20, 2023FDA classified it Class II
Feb 1, 2023Published in FDA’s Enforcement Report

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/59181-abbott-alinity-m-system-recall-calibration-errors-may-cause-misconfiguration">Abbott Alinity m System Recall: Calibration Errors May Cause Misconfiguration (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-1009-2023 (December 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1009-2023 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.