Device recall: Alinity m System, Part No. 08N53-002

Class II FDA enforcement event 89167. Recall start date: 6 Dec 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Abbott Molecular, Inc. started this device recall on 6 Dec 2021. The firm address in the FDA record is in Des Plaines, IL. FDA put the recall in Class II. FDA event 89167 has 1 product record. The first FDA enforcement report date is 12 Jan 2022. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France,…

Recalling firm

Abbott Molecular, Inc., Des Plaines, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 89167: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0461-2022	Alinity m System, Part No. 08N53-002	742 devices	Class II	Ongoing	12 Jan 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 20

Other events of the firm

Other FDA enforcement events of Abbott Molecular, Inc.
Initiated	Product (first record)	Type	Class	Records
28 Apr 2025	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (	Device	Class II	2
20 Mar 2025	The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a	Device	Class II	1
12 Sep 2024	Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF	Device	Class II	2
20 Mar 2024	Alinity m System, Part Number: 08N53-002	Device	Class II	1
1 Feb 2024	In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13	Device	Class III	3
30 Oct 2023	Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse	Device	Class II	1
9 Dec 2022	Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample	Device	Class II	1
22 Nov 2022	Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096	Device	Class II	2
11 Nov 2022	Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.	Device	Class II	1
12 Oct 2022	Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use	Device	Class II	1

Abbott Molecular, Inc.: all 20 events

Official channels

FDA enforcement report Z-0461-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 89167. https://recallregister.com/fda/ii/89167/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France,…
What quantity of product is in FDA event 89167?: The FDA record gives this quantity: 742 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.