CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report

Alinity m System recalled by Abbott Molecular

Abbott Molecular is recalling Alinity m System. The recall was initiated on 9 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 08N53-002

Quantity recalled918 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1009-2023
FDA event ID: 91286
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Ongoing
Recall initiated: 9 Dec 2022
FDA classified: 20 Jan 2023
Reported: 1 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Dec 2022	Recall initiated by company
20 Jan 2023	Classified by FDA	+42 days
1 Feb 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

Where it was distributed

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number: 08N53-002

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Abbott Molecular

All 36

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled	Abbott Molecular	Other	Nationwide
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled	Abbott Molecular	Other	Nationwide
30 Apr 2025Device	CLASS II	The Alinity m System is designed to automate the steps recalled	Abbott Molecular	Other	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide

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