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Abbott Diagnostics Technologies AS

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Abbott Diagnostics Technologies AS is a medical device manufacturer, with 25 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class A and B) and 2 FDA recalls as of 14 Nov 2026.

Devices
25
FDA recalls
21 ongoing since 2021 (2 open in total)
1 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 17
  • EUDAMED 8
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class I 10
  • FDA Class II 6
  • EU Class A 5
  • EU Class B 3
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • DUNS 515324122

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Abbott Diagnostics Technologies AS makes

The company manufactures point-of-care clinical chemistry analysers for in vitro diagnostics (IVD), including the Afinion 2 system for rapid testing. It produces HbA1c reagents and controls, such as the Afinion HbA1c and Alere Afinion HbA1c, alongside microalbumin reagents and controls like the Afinion ACR and its associated controls.

These devices are classified as Class I and Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue25

Newest first, rows 1-25 of 25

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Rows 1-25 of 25

Company details

DUNS number
515324122
Phone
1-866-216-9505

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 17 Jun 2024 Z-2736-2024 Class II Ongoing Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.via FDA establishment Abbott Diagnostics Technologies AS Distribution: US Nationwide distribution in the states of AZ, IN, MA, MN, and OH. Submission number: K171650

  • 2020

    • 23 Mar 2020 Z-2192-2020 Class II Open since 2020 The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.via FDA establishment Abbott Diagnostics Technologies AS Distribution: Distribution was made to NJ. There was no direct government/military distribution. Foreign distribution was made to…
      Full distribution text Distribution was made to NJ. There was no direct government/military distribution. Foreign distribution was made to Canada, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Denmark, Finland, France, Georgia, Germany, Guatemala, Hong Kong, Iceland, India, Italy, Ivory Coast, Japan, Korea, Madagascar, Malaysia, Mexico, Mongolia, Myanmar, The Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Timur, Trinidad & Tobago, United Kingdom, and Zimbabwe.
      Submission numbers: K182988, K180296

Sites1

Frequently asked questions

How many devices does Abbott Diagnostics Technologies AS have in the registry?

The registry currently lists 25 devices for Abbott Diagnostics Technologies AS. Devices recorded under merged duplicate company entries are counted once.

Which registries list Abbott Diagnostics Technologies AS's devices?

Among its 25 most recently registered devices, Abbott Diagnostics Technologies AS has devices listed in EUDAMED (8 devices), FDA 510(k) (1 device) and FDA GUDID (17 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Abbott Diagnostics Technologies AS's devices fall under?

Among its 25 most recently registered devices, the classes recorded for Abbott Diagnostics Technologies AS's devices are Class I, Class II, IVDR Class A and IVDR Class B. Each device page shows its own class and authorisation.

Are there FDA recall records for Abbott Diagnostics Technologies AS?

FDA recall records list 2 recalls initiated by Abbott Diagnostics Technologies AS, the most recent initiated on 17 Jun 2024. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Abbott Diagnostics Technologies AS in the registry?

The most recently registered devices listed for Abbott Diagnostics Technologies AS include NycoCard READER II, Afinion 2, Afinion Lipid Panel Control and Afinion Lipid Panel.

Generated automatically from registry data and not verified by a human reviewer.