Abbott Diagnostics Scarborough, Inc.

FDA recalling firm · 3 enforcement events · 7 product records · 2025–2026 · ME

Abbott Diagnostics Scarborough, Inc. has 3 FDA enforcement events on this register (7 product records) between 2025 and 2026: 3 device; the busiest year was 2025 with 2.

0% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in ME.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
9 Feb 2026	Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable	Device	Class II	1	Ongoing
4 Mar 2025	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No	Device	Class II	3	Ongoing
4 Mar 2025	Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No	Device	Class II	3	Ongoing

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Abbott Diagnostics Scarborough, Inc. by year initiated.

Questions and answers

How many FDA recalls has Abbott Diagnostics Scarborough, Inc. had?

3 enforcement events (7 product records) on this register, 2025–2026: 3 device.

Are any Abbott Diagnostics Scarborough, Inc. recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Abbott Diagnostics Scarborough, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.