ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
Received Jun 26, 2026 · Event occurred Jun 10, 2026
Report 1221359-2026-00187 · MDR key 25635674
Device
Generic name
Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinic
Manufacturer
Abbott Diagnostics Scarborough, Inc.Catalog number
192-000J
Lot number
000X199809
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. D2A - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS. THE INVESTIGATION IS ONGOING; A SUPPLEMENT REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 2.0 ASSAY WITH TWO (2) PATIENTS ON (B)(6) 2026. THIS REPORT IS FOR PATIENT AND TEST ONE (1) OF TWO (2). RETESTING WAS PERFORMED WITH A DIFFERENT IDNOW INSTRUMENT WHICH PRESENTED A NEGATIVE RESULT. THE CUSTOMER INDICATED THAT PATIENTS WERE ASYMPTOMATIC AND THAT THE PATIENTS WERE TREATED AS COVID-19 NEGATIVE PATIENTS. NO NEGATIVE IMPACT WAS REPORTED AS A RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.