ID NOW COVID-19 2.0 TEST KIT 24T CANADA
Received May 26, 2026 · Event occurred May 10, 2026
Report 1221359-2026-00173 · MDR key 25285598
Device
Generic name
Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets
Manufacturer
Abbott Diagnostics Scarborough, Inc.Catalog number
193-000C
Lot number
00X201380A
Product problems
- False Positive Result
Patient
21 MO · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 193-000C THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2026 WITH A NASOPHARYNGEAL SAMPLE. A FOLLOW UP PCR TEST PERFORMED ON THE SAME DAY AT A DIFFERENT FACILITY RETURNED NEGATIVE RESULTS FOR COVID-19. THE PATIENT WAS ISOLATE UNTIL THEY WERE CONFIRMED NEGATIVE BY PCR. NO OTHER PATIENT IMPACT WAS REPORTED.