ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
Received Jun 16, 2026 · Event occurred May 27, 2026
Report 1221359-2026-00177 · MDR key 25524831
Device
Generic name
Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets
Manufacturer
Abbott Diagnostics Scarborough, Inc.Catalog number
192-000J
Lot number
000X189504
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2026. ADDITIONAL TESTING WAS PERFORMED ON THE SAME DAY WITH A RAPID ANTIGEN TEST (BRAND: UNKNOWN) WHICH GENERATED A NEGATIVE RESULT. PER THE CUSTOMER THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT AND 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. 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 REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.