ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

Additional Manufacturer Narrative

B3 -THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED 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 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. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON MULTIPLE PATIENTS ON AN UNKNOWN DATE ON UNKNOWN SAMPLE TYPES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY 2.0 PERFORMED ON AN UNKNOWN DATE ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM: UNKNOWN) ON AN UNKNOWN DATE WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.