ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
Received Jun 26, 2026 · Event occurred Jun 18, 2026
Report 1221359-2026-00190 · MDR key 25635940
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
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE IDNOW COVID-19 2.0 ASSAY ON (B)(6) 2026 WITH AN IMMEDIATELY TESTED NASOPHARYNGEAL SAMPLE. ADDITIONAL TESTING WAS PERFORMED WITH AN ANTIGEN TEST USING A NASOPHARYNGEAL SAMPLE THAT PRESENTED A NEGATIVE RESULT. NO ADDITIONAL INFORMATION WAS REPORTED.
Additional Manufacturer Narrative
D2A - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4: 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. THE INVESTIGATION IS ONGOING; A SUPPLEMENT REPORT WILL BE SENT UPON COMPLETION.