COBAS SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT SYSTEM

Additional Manufacturer Narrative

PRODUCT ISSUE FOUND/NO SYSTEMIC IMPACT. THE DISCREPANCY OBSERVED IS MOST LIKELY DUE TO INTERFERENCE FROM A HIGH VIRAL LOAD OF FLU A AND A LOW VIRAL LOAD OF SARS. ACCORDING TO THE METHOD SHEET UNDER PROCEDURAL LIMITATIONS, FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED, OR HANDLED; IF THERE IS INSUFFICIENT RNA TO BE DETECTED; OR IF ONE OR MORE TARGET VIRUSES INHIBIT THE AMPLIFICATION OF OTHER TARGETS. IT IS POSSIBLE THAT THE VIRAL LOAD OF THE SARS INFECTION WAS LOW AT THE TIME OF COLLECTION.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS LIAT ANALYZER WAS (B)(6). INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT FOR A SINGLE PATIENT SAMPLE TESTED WITH THE COBAS SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM. IT WAS REPORTED THAT THE SAMPLES INITIALLY GENERATED POSITIVE RESULTS FOR INFLUENZA A AND SARS-COV-2 AND NEGATIVE RESULTS FOR INFLUENZA B. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT LIAT ANALYZER AND GENERATED A POSITIVE RESULT FOR INFLUENZA A AND NEGATIVE RESULTS FOR INFLUENZA B AND SARS-COV-2.