COBAS® LIAT® ANALYZER

Additional Manufacturer Narrative

THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST REAGENT LOT NUMBER IS 40108M WITH AN EXPIRATION DATE OF 31-DEC-2025. ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS, ABNORMAL PCR STEPS, AND LOOSE THERMAL SENSOR WIRING. OVERALL ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES HAVE BEEN LAUNCHED. THE IMPLEMENTATION OF BOTH THE SOFTWARE AND THE UPDATED SCRIPT HAVE SHOWN A REDUCTION IN THE CALCULATED FALSE POSITIVE RATE. CONSIGNEES HAVE BEEN NOTIFIED.

Description of Event or Problem

A CUSTOMER FROM THE UNITED STATES GENERATED 3 POTENTIAL FALSE POSITIVE RESULTS WHILE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE FIRST SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR INFLUENZA B. THE SAME SAMPLE WAS RETESTED ON THE SAME LIAT ANALYZER GENERATING A NEGATIVE RESULT FOR INFLUENZA B. THE SECOND SAMPLE INITIALLY GENERATED POSITIVE RESULTS FOR INFLUENZA A, INFLUENZA B, AND SARS-COV-2. THE SAME SAMPLE WAS RETESTED ON THE SAME LIAT ANALYZER GENERATING A NEGATIVE RESULT FOR ALL TARGETS (INFLUENZA A, INFLUENZA B, AND SARS-COV-2). THE THIRD SAMPLE INITIALLY GENERATED A POSITIVE RESULT SARS-COV-2. THE SAME SAMPLE WAS RETESTED ON THE SAME LIAT ANALYZER GENERATING A NEGATIVE RESULT FOR SARS-COV-2. THE REPEAT RESULTS WERE DEEMED CORRECT.

Additional Manufacturer Narrative

THE FOLLOWING INFORMATION HAS BEEN UPDATED. IN H11, IT ORIGINALLY STATES: ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS, ABNORMAL PCR STEPS, AND LOOSE THERMAL SENSOR WIRING. OVERALL, ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH-RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES HAVE BEEN LAUNCHED. THE IMPLEMENTATION OF BOTH THE SOFTWARE AND THE UPDATED SCRIPT HAVE SHOWN A REDUCTION IN THE CALCULATED FALSE POSITIVE RATE. CONSIGNEES HAVE BEEN NOTIFIED. THE CORRECT INFORMATION FOR H11 SHOULD BE: ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS AND ABNORMAL PCR STEPS. OVERALL, ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH-RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES HAVE BEEN LAUNCHED. THE IMPLEMENTATION OF BOTH THE SOFTWARE AND THE UPDATED SCRIPT HAVE SHOWN A REDUCTION IN THE CALCULATED FALSE POSITIVE RATE. CONSIGNEES HAVE BEEN NOTIFIED.