Abbott Diagnostics Scarborough, Inc.
FDA adverse event reports naming Abbott Diagnostics Scarborough, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT DIAGNOSTICS SCARBOROUGH, INC..
- Total reports
- 11,745
- Deaths
- 7
- Injuries
- 380
- Malfunctions
- 11,356
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Reagents, 2019-Novel Coronavirus Nucleic AcidQJR5,410
- Coronavirus Antigen Detection Test System.QKP5,020
- Test, Hiv DetectionMZF979
- Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient SettingsQWR148
- Over-The-Counter Covid-19 Antigen TestQYT104
- Real Time Nucleic Acid Amplification SystemOOI41
- Antisera, All Groups, Streptococcus Spp.GTZ19
- Glucose-6-Phosphate Dehydrogenase (Erythrocytic), ScreeningJBF7
- Plasmodium Spp. Detection ReagentsOAX5
- Influenza A And Influenza B Multiplex Nucleic Acid AssayOZE3
Recent recalls
- 2026-03-13Open, ClassifiedUnder Investigation by firm
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
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
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
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
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
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-15Open, ClassifiedProcess change control
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
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