COBAS® LIAT® ANALYZER

Additional Manufacturer Narrative

NO PRODUCT PROBLEM HAS BEEN FOUND. THE ROOT CAUSE OF THE BARCODE MISREADING COULD NOT BE CLEARLY IDENTIFIED. THE USED BARCODE SYMBOLOGY IS CODABAR. THIS BARCODE TYPE DOES NOT HAVE A CHECK DIGIT. USING BARCODES WITHOUT A CHECKSUM IS NOT RECOMMENDED AS IT POSES AN INCREASED RISK OF BARCODE MISREADS. IT IS RECOMMENDED TO SELECT SAFE BARCODE TYPES E.G. BARCODE TYPE CODE 128 CODE 128 IS CONSIDERED SAFE IN RESPECT OF THE BAR PATTERNS AND INCLUDES MANDATORY BUILT-IN CHECKSUMS TO ENSURE DATA SAFETY. THE ALLEGED COBAS LIAT ANALYZER S/N (B)(6) WAS SENT TO THE ROCHE REPAIR CENTER FOR FURTHER INSPECTION AND INVESTIGATION. NO DEGRADATION OF THE BARCODE SCANNER REFLECTIVE SURFACE OR DAMAGE (SCRATCHES, CLOUDY GLASS ETC.) OF THE SCANNER WINDOW WAS FOUND. THE BARCODE SCANNER WORKED AS INTENDED, AND THE LASER BEAM IS STRONG AND WITHIN SPECIFICATIONS. IT SCANNED TEST BARCODE LABELS AND THE REPRINTED BARCODE LABELS SUCCESSFULLY. THE ISSUE COULD NOT BE REPRODUCED. THE INVESTIGATION DETERMINED THAT USING BARCODES WITHOUT A CHECKSUM WAS CONSIDERED A CONTRIBUTING FACTOR, AS IT POSES AN INCREASED RISK OF BARCODE MISREADS, ESPECIALLY WHEN THE PRINTING QUALITY OF THE BARCODE IS INSUFFICIENT.

Description of Event or Problem

THERE WAS AN ALLEGATION OF TWO INCIDENTS OF THE SAMPLE ID BARCODE BEING MISREAD BY THE COBAS® LIAT® ANALYZER. SAMPLE A: (B)(6) 2025 09:27:12 SCFA RUN # 2072 GENERATED A VALID RESULT (SARS-COV-2 DETECTED, CT=17.75; NEGATIVE FOR INFLUENZA A AND INFLUENZA B) FOR THE WRONG SAMPLE ID (B)(6). NO RESULT WAS FOUND FOR THE CORRECT SAMPLE ID (B)(6). SAMPLE B: (B)(6) 2025 09:14:47 SCFA RUN # 2112 GENERATED A VALID RESULT (NEGATIVE FOR ALL TARGETS) FOR THE WRONG SAMPLE ID (B)(6). (B)(6) 2025 08:23:39 SCFA RUN # 2124 GENERATED A VALID RESULT (NEGATIVE FOR ALL TARGETS) FOR THE CORRECT SAMPLE ID (B)(6). (B)(6) 2025 08:23 THERE WAS A WARNING MESSAGE 'INVALID BARCODE: (B)(6) ERROR CODE: (0XB06)' WHICH COULD INDICATES THAT THE SAMPLE ID BARCODE WAS ATTEMPTED TO BE ADDED MANUALLY BUT FAILED. THE NORMAL SCAN SEQUENCE (SCAN ASSAY TUBE, SCAN SAMPLE ID, SCAN ASSAY TUBE AGAIN) INDICATES THAT THE BARCODES WERE SCANNED BY THE BARCODE SCANNER OF THE COBAS LIAT ANALYZER WITHOUT ANY PROBLEMS.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.