MAUDE Adverse Event Report: Abbott Diagnostics Scarborough, INC. ID NOW COVID-19 2.0 TEST KIT 24T (EUA); Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinic

Catalog Number	192-000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction

• Brand Name: ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
• Common Device Name: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinic
• Manufacturer (Section D): Abbott Diagnostics Scarborough, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; +1(661)388-8803
• MDR Report Key: 50937602
• Report Number: 1221359-2026-00215
• Device Sequence Number: 10739699
• Product Code: QWR
• UDI-Device Identifier: 00811877011354
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K221925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 192-000
• Device Lot Number: 000X199851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown