COBAS® SARS-COV-2 & INFLUENZA A/B

Additional Manufacturer Narrative

ROCHE HAS RECEIVED COMPLAINTS FROM CUSTOMERS USING COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT SYSTEM, LOT 40422A. CUSTOMERS ARE ALLEGING AN INCREASED NUMBER OF INITIAL POSITIVE SARS-COV-2 RESULTS THAT WERE NEGATIVE UPON RETESTS ON THE SAME PLATFORM AND/OR ON OTHER PLATFORMS. BASED ON AN INVESTIGATION OF RECENT CASES, THERE IS A LOW OCCURRENCE RATE OF THIS ISSUE WITH COBAS ® SARS-COV-2 & INFLUENZA A/B KIT LOT 40422A. AT THIS OCCURRENCE RATE, THE GENERATION OF FALSE POSITIVE RESULTS IS WITHIN THE US-IVD PRODUCT CLINICAL PERFORMANCE CLAIMS FOR NEGATIVE PERCENT AGREEMENT AT 99.4% (95% CI: 98.3 - 99.8) AND THE OVERALL PRODUCT BENEFITS FOR THE RAPID AND ACCURATE DETECTION OF SARS-COV-2 AND INFLUENZA A/B AS AN AID IN THE DIFFERENTIAL DIAGNOSIS OF THESE INFECTIONS ARE CONSIDERED TO OUTWEIGH THIS RISK WHEN USED ACCORDING TO ITS INTENDED USE. TAKING THE LOW RATE OF FALSE POSITIVE OCCURRENCE AND THE LOW PROBABILITY OF SUBSEQUENT PATIENT SAFETY IMPACTS TOGETHER, THE FALSE POSITIVES ARE UNLIKELY TO CAUSE ADVERSE TRANSIENT OR SEVERE ADVERSE EVENTS. ADDITIONALLY, NO HARM WAS INDICATED IN THE CURRENT CASE. THE PRELIMINARY INVESTIGATION INTO THE COMPLAINT LOT HAS REPRODUCED THE ISSUE AND FINDINGS SUGGEST REAGENT CONTAMINATION AS A POTENTIAL CAUSE. CUSTOMERS HAVE BEEN INSTRUCTED TO DISCONTINUE THE USE OF AND DISCARD ANY REMAINING INVENTORY OF THE COBAS® SARS-COV-2 & INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS ® LIAT SYSTEM, LOT 40422A, AND ROCHE WILL RECORD THE ACTIONS PER 21 CFR 806.

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 QUESTIONABLE SARS-COV-2 RESULTS WITH 19 PATIENT SAMPLES USING THE COBAS SARS-COV-2 & INFLUENZA A/B ASSAY FOR USE ON THE COBAS LIAT ANALYZER. THE ALLEGED SAMPLES INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2. THE SAME SAMPLES WERE REPEATED ON A COMPETITOR PLATFORM (CEPHEID) AND GENERATED NEGATIVE RESULTS. 2 OF THE 19 WERE ALSO REPEATED USING THE SAME LIAT ANALYZER ON THE COBAS SARS-COV-2 & INFLUENZA A/B & RSV ASSAY, GENERATING A NEGATIVE SARS-COV02 RESULT. 4 OF THE 19 SAMPLES WERE REPEATED USING THE SAME LIAT ANALYZER ON THE COBAS SARS-COV-2 & INFLUENZA A/B ASSAY, GENERATING A NEGATIVE SARS-COV-2 RESULT. PLEASE REFER TO THE ATTACHMENT PT-0071657 FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS. IT IS UNKNOWN WHICH RESULTS WERE DEEMED CORRECT.