Lower riskMedical device recall · FDA · Published November 11, 2022
Abbott Alinity m System Recall: Potential for Incorrect Results After Calibration
Abbott recalls Alinity m System with specific serial numbers due to potential for incorrect results after calibration. Affected units may need recalibration to ensure accurate test results.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Take action
Contact the company
📍Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315
“Abbott Alinity m System Recall: Potential for Incorrect Results After Calibration.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/59378-abbott-alinity-m-system-recall-potential-for-incorrect-results-after. Based on FDA recall #Z-1349-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1349-2023%22&limit=1).
The FDA announced on November 11, 2022, that Abbott Molecular, Inc. voluntarily recalled one Abbott Alinity m System containing Amplification Detection Unit #4 due to potential incorrect results. The agency cited the device being returned for use without calibration as the primary hazard.
How to tell if you have it
Abbott Alinity m System, REF 08N53-002
UPC 00884999048034
Alinity m System Serial #01015
ADU Serial #AMP05139
The hazard
The instrument was installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction, it was returned for use without calibration, resulting in a potential for delay of results and incorrect results.
Context
GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls on record since August 4, 2021. Other recent recalls include the Abbott Alinity m Resp-4-Plex AMP Kit (April 28, 2025) and the Abbott Alinity m System (March 20, 2025). Similar recent recalls of diagnostic products include the Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators (December 11, 2025), the Abbott ID NOW Influenza A & B 2 Kit (February 9, 2026), and the Beckman Coulter Access Total T4 Calibrator (March 16, 2026).
How to tell if you have this one
Check for the Alinity m System with serial number 01015 and UDI code (01)00884999048034(11)220505(21)01015(240)08N53-002. The Amplification Detection Unit (ADU) #4 with serial number AMP05139 is also part of the recall.
Brand
Abbott
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Status
Verify if the instrument has been recalibrated after the issue was corrected.
Where it went and when
Where it was distributed
Distributed in Pennsylvania.
Listed by the agency
Not listed
FDA distribution: “US Distribution to state of: PA, a government account.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1349-2023 (November 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1349-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.