LIAISON SARS-COV-2 AG

Description of Event or Problem

IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH. DIASORIN ITALIA S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE NEGATIVE RESULT OF COV-2 ANTIGEN (REF: 311500 LOT 373030).

Additional Manufacturer Narrative

AN INTERNAL TEST HAS BEEN PERFORMED ON 3 LIAISON XL INSTRUMENTS ON LIAISON®SARS COV-2 AG (P/N 311490) KIT LOT 371033, IN COMBINATION WITH LIAISON® CONTROL SARS COV-2 AG (P/N 311491) LOTS 372017 AND 372018 EVALUATING: DIASORIN POSITIVE CONTROLS LOTS 7223070 AND 7223080 IN SINGLE REPLICATE. DIASORIN NEGATIVE CONTROLS LOTS 7222070 (FROM CONTROLS KIT LOT 372017 INVOLVED BY THE PRESENT INVESTIGATION) AND 7222080 IN FIVE REPLICATES QC PANEL SAMPLES IN SINGLE REPLICATE. PLEASE BE INFORMED THAT THE LOTS NUMBER REPORTED ABOVE ARE THE ONES FOR THE CE MARKET VERSION OF THE PRODUCT BUT THE KIT LOT 373030 FOR US MARKET IS THE SAME OF LOT 371033 FOR CE MARKET (THE TWO LOTS FOR US AND CE MARKET SHARE THE SAME FORMULATION AND THEY'RE PART OF THE SAME BULK). IN ALL THE TEST PERFORMED THE DIASORIN CONTROLS LIE WITHIN THE EXPECTED COA RANGES IN ALL REPLICATES TESTED. MOREOVER, THE EXPECTED CLASSIFICATION WAS MET FOR QC PANEL SPECIMENS. PLEASE CONSIDER THAT THE ANALYSIS EXECUTED CONFIRMS PERFORMANCE ALIGNED WITH THE EXPECTATION FOR THE KIT. (B)(4).

Description of Event or Problem

IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH. DIASORIN ITALIA S.P.A. RECEIVED A COMPLAINT ABOUT POTENTIAL FALSE NEGATIVE RESULT OF COV-2 ANTIGEN (REF: 311500 LOT 373030).