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

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	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings.The investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported an unknown number of false positive results with the id now covid-19 2.0 assay taken on unknown dates with an unknown sample type.Although requested, no patient information, including impact or outcome, was provided.
Event or Problem Description
The customer reported an unknown number of false positive results with the id now covid-19 2.0 assay taken on unknown dates with an unknown sample type.Although requested, no patient information, including impact or outcome, was provided.
Additional Manufacturer Narrative
D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings additional information b3: date of event b5: the customer provided additional information indicating that one (1) false positive result occurred on (b)(6)2026 with a nasal sample.D4: lot number, expiration date, primary udi number as a result of obtaining the lot number involved in this event, the investigation has been reopened and is in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported an unknown number of false positive results with the id now covid-19 2.0 assay taken on unknown dates with an unknown sample type.Although requested, no patient information, including impact or outcome, was provided.
Additional Manufacturer Narrative
D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings the required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, complaints against these trend codes are monitored to identify and track any out-of-trend / unexpected performance at the lot and product family level.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue as no information was provided for investigation.
Additional Manufacturer Narrative
D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings.Additional information.B3: date of event.B5: the customer provided additional information indicating that one (1) false positive result occurred on (b)(6) 2026 with a nasal sample.D4: lot number, expiration date, primary udi number.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000m993485 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 192-000 / lot: 000m993485, test base part number 192-430 / lot: 000m993485.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 000m993485 showed that the complaint rate is 0.000912%.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.
Event or Problem Description
The customer reported an unknown number of false positive results with the id now covid-19 2.0 assay taken on unknown dates with an unknown sample type.Although requested, no patient information, including impact or outcome, was provided.

• 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
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 24199996
• Report Number: 1221359-2026-00017
• Device Sequence Number: 14826512
• Product Code: QWR
• UDI-Device Identifier: 00811877011354
• UDI-Public: (01)00811877011354(17)270302(10)000M993485
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2026

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: M993485
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/09/2026; 03/25/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 01/28/2026; 02/11/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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