CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

Abbott Alinity m System recalled by Abbott Molecular

Abbott Molecular is recalling Abbott Alinity m System, distributed in Pennsylvania. The recall was initiated on 11 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAlinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

Quantity recalled1

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-1349-2023
FDA event ID: 91777
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Ongoing
Recall initiated: 11 Nov 2022
FDA classified: 6 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Nov 2022	Recall initiated by company
6 Apr 2023	Classified by FDA	+146 days
12 Apr 2023	Published in enforcement report	+6 days

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

Reason for recall

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.

Product as listed by the FDA

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Where it was distributed

US Distribution to state of: PA, a government account.

Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

Where was it sold?

US Distribution to state of: PA, a government account.

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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