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 INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. 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. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THERE IS INSUFFICIENT INFORMATION TO DO SO.

Description of Event or Problem

THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. NO INFORMATION REGARDING CONFIRMATORY TESTING WAS PROVIDED. THE CUSTOMER REPORTED NO SYMPTOMS FOR THE PATIENT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT OR OUTCOME WAS PROVIDED.