Abbott Diagnostics Scarborough, Inc.
10 Southgate Rd, Scarborough, ME, US
Registered product codes
24 product codes
Recent MDR events
12,939 on file
- ID NOW COVID-19 2.0 TEST KIT 24T (EUA)Jul 19, 2026Malfunction1221359-2026-00198
- ID NOW COVID-19 2.0 TEST KIT 24T (EUA)Jul 19, 2026Malfunction1221359-2026-00199
- ID NOW COVID-19 2.0 TEST KIT 24T (EUA)Jul 19, 2026Malfunction1221359-2026-00200
- ID NOW RSV TEST KIT 24TJul 17, 2026Injury1221359-2026-00197
- DETERMINE HIV-1/2 AG/AB COMBO 25TJul 15, 2026Malfunction1221359-2026-00193
- DETERMINE HIV-1/2 AG/AB COMBO 25TJul 15, 2026Malfunction1221359-2026-00194
- DETERMINE HIV-1/2 AG/AB COMBO 25TJul 15, 2026Malfunction1221359-2026-00196
- DETERMINE HIV-1/2 AG/AB COMBO 25TJul 15, 2026Malfunction1221359-2026-00195
- DETERMINE HIV-1/2 AG/AB COMBO 25TJun 29, 2026Malfunction1221359-2026-00192
- DETERMINE HIV-1/2 AG/AB COMBO 25TJun 29, 2026Malfunction1221359-2026-00191
Recalls
7 on file
- Open, ClassifiedMar 13, 2026
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗ - Open, ClassifiedApr 15, 2025
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗ - Open, ClassifiedApr 15, 2025
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗ - Open, ClassifiedApr 15, 2025
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗ - Open, ClassifiedApr 15, 2025
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗ - Open, ClassifiedApr 15, 2025
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗ - Open, ClassifiedApr 15, 2025
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
View FDA record ↗
Compliance history
Matched by FEI 1221359.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.