CLASS II ONGOING Device recall · Reported 30 Nov 2022 · FDA Enforcement Report

Alinity m System recalled by Abbott Molecular

Abbott Molecular is recalling Alinity m System. The recall was initiated on 12 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled883 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-0268-2023
FDA event ID: 91001
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Ongoing
Recall initiated: 12 Oct 2022
FDA classified: 18 Nov 2022
Reported: 30 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

12 Oct 2022	Recall initiated by company
18 Nov 2022	Classified by FDA	+37 days
30 Nov 2022	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

Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers

Where was it sold?

Worldwide 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
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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