CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report

The Alinity m System is designed to automate the steps recalled

Abbott Molecular is recalling The Alinity m System is designed to automate the steps for nucleic acid testing, distributed nationwide in the US. The recall was initiated on 20 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587

Quantity recalledN/A

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-1665-2025
FDA event ID: 96559
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Ongoing
Recall initiated: 20 Mar 2025
FDA classified: 24 Apr 2025
Reported: 30 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Mar 2025	Recall initiated by company
24 Apr 2025	Classified by FDA	+35 days
30 Apr 2025	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 design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

Product as listed by the FDA

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587

Where was it sold?

Worldwide - US Nationwide distribution.

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
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
1 May 2024Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	Nationwide

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