cobas 8800 System 05412722001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630935390), received between Sep 14, 2018 and Jan 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT WNV RESULTS WITH THE COBAS®WNV KIT (480T) FROM THE COBAS 8800 ANALYZER FOR A SINGLE PATIENT. ON (B)(6) 2025, THE INITIAL SAMPLE GENERATED A REACTIVE RESULT FOR WNV (CT 3.7). THE SAME SAMPLE FROM A DIFFERENT TUBE WAS TESTED ON THE SAME DAY AND GENERATED A NON-REACTIVE RESULT FOR WNV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051226 ↗
• MalfunctionNov 6, 2025False Positive Result; Optical Problem; False Positive Result; Optical Problem

  THERE WAS AN ALLEGATION OF A QUESTIONABLE COBAS® WNV (192T) ASSAY RESULT FOR A DONOR PATIENT SAMPLE TESTED ON A COBAS 8800 ANALYZER. THE INITIAL RESULT WAS REACTIVE. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE NON-REACTIVE BOTH TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488024 ↗
• MalfunctionOct 23, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE COBAS® WNV - 480 ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON COBAS® 8800 SYSTEM. THE INITIAL RESULT WAS REACTIVE. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE NON-REACTIVE BOTH TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369455 ↗
• MalfunctionOct 20, 2023Mechanical Problem; Mechanical Problem

  THERE WAS AN ALLEGATION OF AN ISSUE WITH THE FRONT COVER OF THE COBAS 8800 ANALYZER. THE CUSTOMER ALLEGED THE SAMPLE SUPPLY MODULE FRONT COVER SLAMMED SHUT ON AN OPERATOR'S LEFT INDEX FINGER. THE FIELD APPLICATION SPECIALIST CONFIRMED THE OPERATOR'S FINGER WAS BRUISED AND THE COVER WAS REPORTEDLY NOT SHUTTING SLOWLY AS EXPECTED. THE OPERATOR ALLEGEDLY DID NOT REQUIRE ANY MEDICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978110 ↗
• MalfunctionJan 3, 2022High Test Results; High Test Results

  A CUSTOMER FROM THE US ALLEGED (B)(6) DISCREPANT RESULTS GENERATED FOR ONE PATIENT WHEN USING THE COBAS 8800 SYSTEM (SN# (B)(4)). THE PATIENT SAMPLE PRODUCED A (B)(6) RESULT IN THE INITIAL TESTING. THIS SAMPLE WAS REFLEXED FOR (B)(6) GENOTYPE TESTING, PER NORMAL LAB PROCESS, WHERE IT RECEIVED A (B)(6) RESULT. THE SAMPLE WAS REPEATED ON ANOTHER 8800 SYSTEM AND RECEIVED A TARGET NOT DETECTED RESULT. BOTH THE INITIAL AND RETEST RESULTS WERE REPORTED OUT. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13144051 ↗
• MalfunctionSep 14, 2018Incorrect, Inadequate or Imprecise Result or Readings; Defective Device

  A (B)(6) CUSTOMER ALLEGED DISCREPANT (B)(6) RESULTS FOR PATIENT SAMPLES TESTED WITH THE COBAS® HBV TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS. THE ROCHE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND FOUND A FAILED RESULT FOR PROCESS HEAD TIGHTNESS CHECK WITH SOME LOOSE STOP DISCS ON THE COBAS 8800 SYSTEM'S PROCESSING TRANSFER HEADS, THAT COULD HAVE CAUSED THE ALLEGED DISCREPANT RESULTS. NO HARM OR INJURY WAS REPORTED THROUGH THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878750 ↗