cobas 6800 System 05524245001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630935406), received between Nov 9, 2018 and Oct 8, 2025 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED THAT THE COBAS INFINITY TRANSMITTED INCORRECT PATIENT RESULTS TO THE LABORATORY INFORMATION SYSTEM (LIS). THE ISSUE OCCURED DUE TO AN ABORTED 6800 RUN AS THE SYSTEM COULD NO LONGER DISPOSE OF CLOTTED TIPS DUE TO FULL CLOTTED TIP RACKS. THEREFORE, THE SAMPLES ON THE RUN WERE INVALIDATED WITH 35 OUL^R22 MESSAGES INCLUDING THE U04 FLAG. HOWEVER, THE COBAS INFINITY PROCESSED THE MESSAGES/FLAG AS RESULTS AND 35 PATIENT SAMPLE RESULTS WERE AUTOMATICALLY REPORTED AS "NEGATIVE" IN THE LIS. NOTE, OUT OF THE 35 AFFECTED SAMPLES, 29 WERE LATER RETESTED SUCCESSFULLY AND RECEIVED VALID NEGATIVE RESULTS. FURTHER DETAILS FOR THE SIX SAMPLES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23244919 ↗
• InjuryApr 17, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A FIELD SERVICE REPRESENTATIVE (FSR) WAS ALLEGEDLY AT A CUSTOMER SITE FOR A REPAIR OF THE SOLID WASTE LOCKING SYSTEM ON THE COBAS 6800 INSTRUMENT. THE FSR WAS REPORTEDLY DISPOSING OF THE LIQUID WASTE WITHOUT PROPER EYE PROTECTION WHEN SOME SPLASHED INTO HIS EYES. THE FSR REPORTEDLY WENT TO SEE AN OPTOMETRIST AND AN EYE DOCTOR. THE OPTOMETRIST TOOK A RETINAL PHOTO AND MEASURED THE PRESSURE ON BOTH EYES. THE RETINA IS OK. THE DOCTOR PRESCRIBED PAINKILLERS AND ANTIBIOTICS. IT WAS REPORTED THAT HIS RIGHT EYE IS BETTER AND THE LEFT EYE IS STILL GIVING PAIN AND SWELLING BUT LESS THAN BEFORE.

  Patient problems: Eye Pain

  MAUDE report 19127881 ↗
• InjuryDec 5, 2023Sharp Edges; Sharp Edges

  WE RECEIVED INFORMATION THAT A CUSTOMER CUT HIS OUTER RIGHT THUMB ON THE COBAS 6800 REAGENT STORAGE AIR EXHAUST. THE CUSTOMER REPORTEDLY APPLIED A BANDAID ON THE WOUND AND RECEIVED A TETANUS SHOT FROM THE HOSPITAL EMPLOYEE HEALTH FACILITY. NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: Laceration(s)

  MAUDE report 18266859 ↗
• MalfunctionOct 12, 2021False Positive Result; False Positive Result

  THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FROM A COBAS® 6800 (S/N (B)(4)). A CUSTOMER FROM (B)(6) ALLEGED THAT THEY RECEIVED A POTENTIAL FALSE POSITIVE RESULT FOR A PATIENT¿S SAMPLE WHEN TESTED WITH KIT COBAS 6800/8800 SARS-COV-2 480T. THE CUSTOMER REPORTED THAT A PATIENT¿S SAMPLE TESTED IN CONTROL BATCH 518 GENERATED A SARS-COV-2 POSITIVE RESULT FOR A PATIENT¿S SAMPLE ANALYZED ON THE COBAS® 6800 (S/N (B)(4)). THE PATIENT¿S SAME SAMPLE AND A RECOLLECTED SAMPLE WAS REPEAT TESTED AND TESTED ON THE SAME THE COBAS® 6800 (S/N (B)(4)) AND ON A DIFFERENT PLATFORM (INSTRUMENT NOT PROVIDED) BOTH PLATFORMS GENERATED SARS-COV-2 NEGATIVE RESULTS FOR BOTH THE SAME AND RECOLLECTED SAMPLES. PATIENT SAMPLE WAS COLLECTED USING NASOPHARYNGEAL SWABS IN COBAS PCR MEDIA. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620587 ↗
• MalfunctionNov 9, 2018False Positive Result; Loose or Intermittent Connection; Device Displays Incorrect Message

  A CUSTOMER FROM (B)(6) REPORTED THE GENERATION OF AN INVALID COBAS MPX POSITIVE CONTROL [MPX O (+) CONTROL] DUE TO AN ERROR FLAG (C02H1). WHEN REVIEWING SEVERAL RUNS WITHIN THE CUSTOMER-PROVIDED DATA, IT WAS IDENTIFIED THAT SEVERAL WELLS, CONTAINING SAMPLES OR CONTROLS, HAD THE ERROR CODE P07P, WHICH IS INDICATIVE OF A VOLUME ERROR DURING SUPERNATANT REMOVAL. 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 6800 SYSTEM'S PROCESSING TRANSFER HEADS, THAT WERE LIKELY THE CAUSE FOR THE GENERATION OF THE ERROR CODES. THE ROCHE FIELD SERVICE ENGINEER REPLACED ALL STOP DISCS & O-RINGS ON THIS INSTRUMENT PROCESSING TRANSFER HEAD. THERE IS NO ALLEGATION ON DISCREPANT DONOR SAMPLE RESULTS. WHEN ERROR CODES ARE GENERATED FOR THE COBAS MPX CONTROLS, THE TEST RUN IS INVALIDATED AND ALL DONOR SAMPLES INCLUDED IN THE TEST RUN NEED TO BE REPEAT TESTED PER THE INSTRUCTIONS FOR USE. WHEN THE P0P7 ERROR CODE IS GENERATED FOR A DONOR SAMPLE, THE DONOR SAMPLE NEEDS TO BE REPEAT TESTED PER THE INSTRUCTIONS FOR USE. NO HARM OR INJURY WAS REPORTED THROUGH THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8055672 ↗