Abbott Diagnostics Scarborough, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000014444 FEI 1221359
- Devices
- 20
- Registrations
- EUDAMEDFDA
- FDA recalls
- 77 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Abbott Diagnostics Scarborough, Inc. makes
Abbott Diagnostics Scarborough, Inc. manufactures point-of-care diagnostic devices including the ID NOW COVID-19 2.0, ID NOW Influenza A & B 2, BinaxNOW COVID-19 Ag Card, BinaxNOW COVID-19 Antigen Self Test, ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2, and ALERE NMP22 TEST.
These devices are regulated as Class II and Class III medical devices and are listed in the FDA 510(k) and FDA PMA registries. The company is based in the United States.
Catalogue
Search and filter all 20 devicesCompany details
- EUDAMED SRN
- US-MF-000014444
- FDA FEI number
- 1221359
- EUDAMED status
- Active
- EUDAMED registered name
- Abbott Diagnostics Scarborough, Inc.
- Registered address
- 10 Southgate Road, 04074, Scarborough, United States
- Website
- www.globalpointofcare.abbott
- linkedin.com/company/abbott-
- facebook.com/Abbott
- [email protected]
- Phone
- +1 207 730 5750
- PRRC contact
- Mary Kluck
FDA recalls
FDA recall records list 7 recalls initiated by Abbott Diagnostics Scarborough, Inc., the earliest on 2025-03-04 and the most recent on 2026-02-09. By recorded status: 7 ongoing. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 6
- 2026 1
2026
- 9 Feb 2026 Z-1565-2026 Class II Ongoing It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025
- 4 Mar 2025 Z-1571-2025 Class II Ongoing The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Full distribution text
- 4 Mar 2025 Z-1572-2025 Class II Ongoing The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Full distribution text
- 4 Mar 2025 Z-1573-2025 Class II Ongoing The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Full distribution text
- 4 Mar 2025 Z-1574-2025 Class II Ongoing the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 4 Mar 2025 Z-1575-2025 Class II Ongoing the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 4 Mar 2025 Z-1576-2025 Class II Ongoing the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 4 Mar 2025 Z-1571-2025 Class II Ongoing The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
From the company website
With point-of-care diagnostics, everyday moments can lead to better global health outcomes. Abbott is dedicated to developing point-of-care diagnostic tests that are able to provide invaluable answers to doctors, clinicians and nurses at the right time and where they are most needed.
Frequently asked questions
How many devices does Abbott Diagnostics Scarborough, Inc. have in the registry?
The registry currently lists 20 devices for Abbott Diagnostics Scarborough, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Diagnostics Scarborough, Inc.'s devices?
Among its 20 most recently registered devices, Abbott Diagnostics Scarborough, Inc. has devices listed in EUDAMED (12 devices), FDA 510(k) (7 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Abbott Diagnostics Scarborough, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Abbott Diagnostics Scarborough, Inc.'s devices are Class II, Class III and IVD general. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott Diagnostics Scarborough, Inc.?
FDA recall records list 7 recalls initiated by Abbott Diagnostics Scarborough, Inc., the most recent initiated on 9 Feb 2026. 7 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 Scarborough, Inc. in the registry?
The most recently registered devices listed for Abbott Diagnostics Scarborough, Inc. include BinaxNOW™ Streptococcus pneumoniae Antigen Card (22T), BinaxNOW™ Legionella Urinary Antigen Card (22T), BinaxNOW™ Malaria (25T) and NMP22™ BladderChek™ Test (24T).