cobas Liat Analyzer 07341920190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336100097), received between Jan 28, 2021 and May 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 16, 2021Open, Classified

   Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

   Z-0828-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024False Positive Result; Unable to Obtain Readings; False Positive Result; Unable to Obtain Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309964 ↗
• MalfunctionJul 8, 2021False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM THE US ALLEGED DISCREPANT RESULTS GENERATED ON 3 PATIENT SAMPLES WHEN USING A COBAS® SARS-COV-2 AND INFLUENZA A/B NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM, WHEN COMPARED TO THE RESULTS GENERATED WITH GENEXPERT CEPHEID FOR PATIENT 2 AND 3. PATIENT #1 AND 3 GENERATED FLU B POSITIVE AND PATIENT 2 GENERATED SARS-COV-2 POSITIVE AND FLU B POSITIVE. A REPEAT OF THE SAME SAMPLE FOR PATIENT 1 WITH THE SAME LIAT® SYSTEM WAS NEGATIVE. A NEW SAMPLE WAS RECOLLECTED FOR PATIENT 2 AND TESTED WITH THE GENEXPERT CEPHEID AND GENERATED SARS-COV-2 NEGATIVE, FLU B NEGATIVE. FOR PATIENT 3, A REPEAT TESTING OF THE SAME SAMPLE WITH THE GENEXPERT CEPHEID WAS ALSO NEGATIVE. TWO ADDITIONAL SAMPLES, PATIENTS 4 AND 5, GENERATED POTENTIALLY DISCREPANT RESULTS, FLU B POSITIVE AND SARS COV

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 12140184 ↗
• MalfunctionJan 28, 2021False Positive Result; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  A CUSTOMER IN THE US INITIALLY REPORTED THE GENERATION OF INVALID RESULTS AND ONE DISCREPANT RESULT WHEN USING THE COBAS LIAT SARS-COV-2/FLU TEST ON THE COBAS LIAT SYSTEM. THE ALLEGED SAMPLE GENERATED A SARS-COV-2 NOT DETECTED, FLU A NOT DETECTED, FLU B DETECTED RESULT IN THE ORIGINAL TEST. REPEAT TEST GENERATED NOT DETECTED RESULTS FOR ALL TARGETS. DURING THE REVIEW OF THE DATA PROVIDED FOR INVESTIGATION, IT WAS IDENTIFIED THAT 2 ADDITIONAL SAMPLES HAD FALSE POSITIVE RESULTS FOR SARS-COV-2 AND FLU B. NO PATIENT INFORMATION WAS PROVIDED AND NO HARM WAS INDICATED. THREE MDRS, ONE PER EACH ALLEGED RESULT WILL BE SUBMITTED.

  Patient problems: Anxiety; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 11247389 ↗
• MalfunctionJan 28, 2021False Positive Result; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  A CUSTOMER IN THE US INITIALLY REPORTED THE GENERATION OF INVALID RESULTS AND ONE DISCREPANT RESULT WHEN USING THE COBAS LIAT SARS-COV-2/FLU TEST ON THE COBAS LIAT SYSTEM. THE ALLEGED SAMPLE GENERATED A SARS-COV-2 NOT DETECTED, FLU A NOT DETECTED, FLU B DETECTED RESULT IN THE ORIGINAL TEST. REPEAT TEST GENERATED NOT DETECTED RESULTS FOR ALL TARGETS. DURING THE REVIEW OF THE DATA PROVIDED FOR INVESTIGATION, IT WAS IDENTIFIED THAT 2 ADDITIONAL SAMPLES HAD FALSE POSITIVE RESULTS FOR SARS-COV-2 AND FLU B. NO PATIENT INFORMATION WAS PROVIDED AND NO HARM WAS INDICATED. THREE MDRS, ONE PER EACH ALLEGED RESULT WILL BE SUBMITTED.

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions; Test Result; Unspecified Respiratory Problem

  MAUDE report 11247352 ↗