cobas u 411 Urine Analyzer 4906969001Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04015630925636), received between Sep 26, 2018 and Dec 15, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Computer Operating System Problem” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Data Problem; Data Problem

  THERE WAS AN ALLEGATION OF A SAMPLE MISMATCH ON THE COBAS U 411 URINE ANALYZER. RESULTS WERE ASSIGNED TO THE WRONG SAMPLE (WRONG PATIENT ID). REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802034 ↗
• MalfunctionDec 3, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE NEGATIVE LEUCOCYTE RESULTS WITH THE CHEMSTRIP 10 UA FROM THE COBAS U 411 URINE ANALYZER FOR 6 SAMPLES. 1 EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS NEGATIVE. DURING A MANUAL MICROSCOPIC RUN, IT SHOWED POSITIVE CLUSTERS OF 50/100 CLUMPS OF WHITE BLOOD CELL (WBC). THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THE MICROSCOPIC READING OF POSITIVE WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707779 ↗
• MalfunctionNov 4, 2025Computer Operating System Problem; Computer Operating System Problem

  THE INITIAL REPORTER ALLEGED INSTANCES OF PATIENT SAMPLE MISMATCH ON A COBAS U 411 URINE ANALYZER, SOFTWARE VERSION 3.3.3. THE CUSTOMER ALLEGED THAT THE NUMBER ASSIGNED DURING SCANNING DIFFERS FROM THE NUMBER IN THE WORK LIST. FOR EXAMPLE, THE USER ENTERED THE NUMBERS 27, 57, AND 63. WHEN REVIEWING THE WORK LIST, DIFFERENT SAMPLE NUMBERS OF 10, 19, AND 27 WERE ASSIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468605 ↗
• MalfunctionNov 3, 2025Computer Operating System Problem; Computer Operating System Problem

  THE INITIAL REPORTER STATED THEY HAVE HAD INCIDENTS OF SAMPLE MISMATCHES ON THE COBAS U 411 URINE ANALYZER. THE CUSTOMER STATED THEY ENTER SAMPLE IDENTIFIERS INTO A WORKLIST ON THE ANALYZER SOFTWARE USING A BARCODE READER. THE CUSTOMER ALLEGES THAT THE SOFTWARE WILL DELETE SAMPLE IDENTIFIERS WITHOUT USER REQUEST AND WILL ANALYZE THEM RANDOMLY LEADING TO A MISMATCH OF PATIENT DATA WITH THE ENTERED SAMPLE IDENTIFIERS. THE CUSTOMER ALLEGES THAT THE ISSUE ALSO LEADS TO WRONG CALIBRATION OR OTHER UNIDENTIFIED MISMATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457848 ↗
• MalfunctionAug 22, 2024False Negative Result; False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT NEGATIVE RESULTS FOR 1 PATIENT TESTED WITH THE COMBUR 10 TEST M URINE TEST STRIP ON A COBAS U411 URINE ANALYZER. THE SAMPLE OBTAINED A NEGATIVE RESULT WHEN TESTED ON THE INSTRUMENT. THE LEUCOCYTES RESULT FROM THE URINE TEST STRIP WAS 100 LEUCOCYTES/ L (CHECKED BY VISUAL VERIFICATION). THE QC WAS PERFORMED AND IT ALSO OBTAINED NEGATIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028496 ↗
• MalfunctionFeb 16, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON A COBAS U 411 URINE ANALYZER. MULTIPLE TEST PARAMETERS ARE AFFECTED. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT LEUKOCYTE VALUES. THE SAMPLE INITIALLY RESULTED IN A LEUKOCYTE VALUE OF 500 LEUKOCYTES/UL. THE SAME SAMPLE WAS REPEATED, RESULTING IN A NEGATIVE LEUKOCYTE VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18725239 ↗
• MalfunctionDec 21, 2023Computer Operating System Problem; Computer Operating System Problem

  THERE WAS AN ALLEGATION OF REGARDING AN ALLEGED SAMPLE MISMATCH ON A COBAS U 411 URINE ANALYZER. REPORTEDLY, THE SAMPLE RESULTS WERE ASSIGNED TO THE WRONG PATIENT. THE CUSTOMER STATED THAT A SAMPLE WAS SCANNED AND NOT MEASURED IMMEDIATELY. A SECOND SAMPLE WAS THEN SCANNED AND THE RESULT OF THE SECOND SAMPLE WAS ASSIGNED TO THE FIRST SAMPLE. NO INCORRECT PATIENT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374952 ↗
• MalfunctionAug 9, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH A COBAS U 411 URINE ANALYZER. THE CUSTOMER ALLEGED THE SEQUENCE NUMBER OF THE PATIENT¿S SAMPLE WAS CHANGED LEADING TO A MISMATCH IN PATIENT RESULTS. THE SPECIFIC RESULTS WERE NOT PROVIDED. THE CUSTOMER REVIEWED THE URINE SEDIMENT FROM THE TEST AND PERFORMED A VISUAL VERIFICATION WHERE THE ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494769 ↗
• MalfunctionMay 2, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER STATED THEY HAD AN ISSUE WITH MISMATCHED DATA ON THE COBAS U 411 URINE ANALYZER. THERE APPEARS TO BE SOME OVERLAP OF DATA AS DATA MEASURED FROM A FIRST SAMPLE WILL BE ASSOCIATED WITH A SECOND SAMPLE. FOR EXAMPLE, SAMPLE A WILL RUN ON THE ANALYZER AND RESULTS WILL BE MEASURED FOR THIS SAMPLE. SAMPLE B IS THEN RUN ON THE ANALYZER AND NO RESULTS WILL BE MEASURED. SAMPLE C IS THEN RUN ON THE ANALYZER AND THE RESULTS MEASURED FROM SAMPLE B THEN APPEAR FOR SAMPLE C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855055 ↗
• MalfunctionDec 27, 2022Delayed Program or Algorithm Execution; Delayed Program or Algorithm Execution

  THE INITIAL REPORTER ALLEGED THERE WAS A MISMATCH OF PATIENT DATA FOR AN UNSPECIFIED NUMBER OF URINE PATIENT SAMPLES TESTED ON THE COBAS U 411 URINE ANALYZER. THE SOFTWARE VERSION OF THE ANALYZER IS 3.3.3.0019. ON (B)(6) 2022, THE REPORTER OBSERVED THAT THE RESULTS OBTAINED DID NOT MATCH THE ID NUMBERS. THEY THEN PROCESSED SAMPLE BY SAMPLE. ON (B)(6) 2022, THE ISSUE PERSISTED. THE REPORTER NOTED THAT WHEN TWO SAMPLES WERE PROCESSED, TWO RESULTS COME OUT BUT THE FIRST COMES OUT WITH A DIFFERENT ID IN THE INDICATED FREE SEQUENCE AND THE SECOND COMES OUT WITH THE ID OF THE SAMPLE THAT WAS ENTERED FIRST. THE REPORTER USED A WORKLIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052369 ↗
• MalfunctionNov 15, 2022Optical Obstruction; Optical Obstruction

  THE INITIAL REPORTER STATED THERE IS A MISMATCH OF PATIENT DATA FOR ONE PATIENT SAMPLE TESTED ON THE COBAS U 411 ANALYZER. WHEN MANUALLY RUNNING PATIENT SAMPLES ON THE U 411, TWO TEST STRIPS ARE TESTED SEQUENTIALLY ON THE ANALYZER WITHOUT ASSIGNING A PATIENT ID TO EACH TEST STRIP MEASUREMENT. THE FIRST STRIP WILL NOT BE READ BY THE ANALYZER AND THEN THE RESULTS OF THE SECOND STRIP ARE ASSIGNED TO THE PATIENT/IDENTIFIER OF THE FIRST TEST STRIP. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT WAS MEASURED TWICE. THE FIRST MEASUREMENT DATA WAS PROVIDED FROM THE CUSTOMER'S HOST SYSTEM AS FOLLOWS: COLOR = YELLOW, DENSITY = 1015.000 (NO UNITS PROVIDED), PH = 9.0, NITRITES = POSITIVE, LEUKOCYTES = 500.00 (NO UNITS PROVIDED), PROTEIN = 25.00 MG/DL, GLUCOSE = NORMAL MG/DL, KETONES = NEGATIVE, UROBILINOGEN = NORMAL MG/DL, BILIRUBIN = NEGATIVE. THE SECOND MEASUREMENT DATA WAS PROVIDED FROM A PRINTOUT OF THE U 411 ANALYZER: DENSITY = 1.025 (NO UNITS PROVIDED), PH = 5, LEUKOCYTES = NEGATIVE, NITRITES = NEGATIVE, PROTEIN = NEGATIVE, GLUCOSE = NORMAL, KETONES = NEGATIVE, URIBILINOGEN = NORMAL, BILIRUBIN = NEGATIVE, ERYTHROCYTES = NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796058 ↗
• MalfunctionMay 11, 2022Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS U 411 URINE ANALYZER. THE ALLEGED ISSUE WAS A MISMATCH OF SAMPLE IDS. A SAMPLE ID WAS DISPLAYED AS "SUPERVISOR" FOR THE FIRST SAMPLE INSTEAD OF THE CORRECT SAMPLE ID. THE SECOND SAMPLE RESULT HAD THE FIRST SAMPLE'S SAMPLE ID. THE RESULT, DISPLAYED FOR THE SECOND SAMPLE, BELONGED TO THE FIRST PATIENT SAMPLE. THE REMAINING SAMPLES ON THE LIST WERE ALSO MISMATCHED. THE CUSTOMER DISCOVERED THE ISSUE BY COMPARING THE RESULTS WITH A NEW URISYS 1100. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SOFTWARE VERSION IS 3.3.2.0007.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14358534 ↗
• MalfunctionJul 8, 2021False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THAT AN UNSPECIFIED NUMBER OF PATIENT SAMPLES SHOWED LEUKOCYTE RESULTS FROM THE U 411 ANALYZER THAT WERE DIFFERENT FROM VALUES OBSERVED UPON MICROSCOPIC EVALUATION OF THE SAMPLES. RESULTS WERE MANUALLY EDITED ON THE U 411 ANALYZER TO 100/UL OR 500/UL. AN EXAMPLE WAS PROVIDED FOR ONE PATIENT SAMPLE WHICH HAD DISCREPANT LEUKOCYTE RESULTS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN UNKNOWN VALUE FOR LEUKOCYTES, BUT THIS VALUE WAS LIKELY NEGATIVE. MICROSCOPIC EVALUATION OF THE SAMPLE DETERMINED IT CONTAINS 21-30 LUKOCYTES/HPF. THE RESULT ON THE ANALYZER WAS EDITED TO 500/UL. THE TEST STRIP LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136120 ↗
• MalfunctionOct 17, 2018Patient Data Problem; Patient Data Problem

  THE CUSTOMER STATED THAT A SAMPLE MISMATCH OCCURRED ON THE COBAS U 411 ANALYZER. THE CUSTOMER STATES THAT A MISMATCH OCCURRED BETWEEN THE IDENTIFIER NUMBER OF THE PATIENT SAMPLE AND THE TEST STRIP RESULTS DUE TO THE INSTRUMENT NOT MATCHING THE SAMPLE WITH THE WORK LIST. THE USER WAS ABLE TO DETECT THE ISSUE AND REPROCESSED THE SAMPLE. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973975 ↗
• MalfunctionOct 10, 2018Patient Data Problem; Patient Data Problem

  THE CUSTOMER ALLEGED A POSSIBLE PATIENT SAMPLE MISMATCH ON A COBAS U 411 ANALYZER WITH AN UNSPECIFIED SOFTWARE VERSION. THE CUSTOMER STATED THAT THERE WAS A MISMATCH RESULT BETWEEN A PATIENT ID NUMBER AND THE TEST STRIP RESULT BECAUSE THE INSTRUMENT DID NOT CORRECTLY MATCH THE SAMPLE WITH THE WORK LIST. THE CUSTOMER REALIZED THE PROBLEM AND REPROCESSED THE PATIENT SAMPLE. NO INCORRECT RESULTS WERE DELIVERED TO THE PATIENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A FIELD ENGINEERING SPECIALIST REPLACED THE STRIP SENSOR AND THE DISPLAY MODULE. THE COBAS U411 SOFTWARE VERSION WAS UPDATED TO VERSION 3.3.3. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952741 ↗
• MalfunctionSep 26, 2018Computer Software Problem; Computer Software Problem

  THE CUSTOMER ALLEGED A POSSIBLE PATIENT SAMPLE MISMATCH ON THE COBAS U 411 ANALYZER WITH SOFTWARE VERSION 3.3.3. THE CUSTOMER STATED THERE ARE SOME INSTANCES WHERE PATIENT SAMPLES WERE PROCESSED BY THE ANALYZER BUT THE PATIENT HAS BEEN DELETED FROM THE WORK LIST WITH NO RESULTS PRODUCED FOR THOSE PATIENTS. THE CUSTOMER THINKS THE RESULTS FOR THE AFFECTED PATIENTS MAY HAVE BEEN ASSIGNED TO OTHER PATIENTS. THE CUSTOMER WAS UNABLE TO PROVIDE ANY SPECIFIC RESULTS OR PATIENT DATA. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE CUSTOMER SITE AND RELOADED SOFTWARE VERSION 3.3.3 AND REPLACED THE DISPLAY MODULE. THE CUSTOMER CONTINUED TO HAVE THE ISSUE. THE CUSTOMER PROVIDED THE INSTRUMENT DATABASE AND ERROR LOG FOR INVESTIGATION. ACCORDING TO THE DATA PROVIDED, THE INSTRUMENT WORKS AS SPECIFIED AND NO ABNORMAL BEHAVIOR WAS IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER FOR THE INVESTIGATION, HOWEVER, NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE CUSTOMER STATED THE INSTRUMENT IS CURRENTLY WORKING FINE. WITH INSUFFICIENT INFORMATION FROM THE CUSTOMER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE INVESTIGATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910252 ↗