cobas u 601 urine analyzer 06390498001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630932443), received between Jan 25, 2019 and Jul 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052861 ↗
• MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings; Intermittent Program or Algorithm Execution

  WE RECEIVED AN ALLEGATION OF A SAMPLE MISMATCH FOR EIGHTY (80) URINE PATIENT SAMPLES TESTED ON THE COBAS U 601 URINE ANALYZER. THE REPORTER STATED THAT SOME PATIENT SAMPLES HAD AN ERYTHROCYTE RESULT OF "+3" OR "+4", BUT NO ERYTHROCYTES WERE DETECTED IN THE MICROSCOPIC READING. THEY SUSPECT A SAMPLE MISMATCH, AS THE SAMPLE IN ONE RACK POSITION WAS WAITING FOR THE SAMPLE RACK IN ANOTHER POSITION OF THE FOLLOWING RACK TO BE COMPLETED BEFORE THE RESULT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24295655 ↗
• MalfunctionJan 30, 2026False Negative Result

  WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE NEGATIVE RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED WITH COBAS U PACK URINE TEST STRIP ON A COBAS U 601 URINE ANALYZER. THE SAMPLE WAS TESTED ON THE COBAS U 601 URINE ANALYZER AND OBTAINED A NEGATIVE LEU (LEUCOCYTES) RESULT. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, PROMPTING THE CUSTOMER TO EXAMINE THE SAMPLE MICROSCOPICALLY AND OBSERVE NEUTROPHILS, SUGGESTING A POSITIVE RESULT. NO QUESTIONABLE RESULT WAS RELEASED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221540 ↗
• MalfunctionMar 30, 2023Optical Problem; Missing Test Results; Optical Problem; Missing Test Results

  THE CUSTOMER ALLEGED SAMPLE MISMATCH WHILE WORKING IN A SEQUENCE MODE WITHOUT BARCODES ON THE COBAS 6500 U601 URINE ANALYZER USING SOFTWARE VERSION V2.3.7. THE CUSTOMER STARTED ROUTINE TESTING WITH A SAMPLE IDENTIFIED AS N1 AND RACK NUMBER: 0001 SO THAT TUBES IDENTIFIED AS N6-N10 WENT TO RACK NUMBER: 0002, TUBES IDENTIFIED AS N11-N15 TO RACK NUMBER: 0003, TUBES IDENTIFIED AS N16-N20 TO RACK NUMBER: 0004, AND TUBES IDENTIFIED AS N21-N25 WERE EXPECTED TO GO TO RACK NUMBER: 0005, BUT A MISMATCH OCCURRED. THE SAMPLE IDENTIFIED AS N25 WAS IN POSITION 3 OF THE RACK AND A SAMPLE IDENTIFIED AS N27 WAS IN POSITION 4. AS A RESULT, ALL OTHER NUMBERS WERE SHIFTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648489 ↗
• MalfunctionJun 7, 2022Patient Data Problem; Patient Data Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE FOR THE COBAS U 601 URINE ANALYZER. THE ALLEGED ISSUE WAS THAT A SAMPLE BARCODE ID WAS INCORRECTLY READ. SAMPLE B DISPLAYED SAMPLE A'S BARCODE AND ANOTHER SET OF RESULTS. SAMPLE A HAD THE CORRECT BARCODE ID AND RESULTS. THE BARCODE ID WAS NOT READ CORRECTLY FOR SAMPLE B. THE RESULTS WERE MANUALLY CHECKED AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SOFTWARE VERSION IS 2.2.10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621705 ↗
• MalfunctionSep 10, 2021Optical Problem; Optical Problem

  THE INITIAL REPORTER ALLEGED A POSSIBLE SAMPLE MISMATCH ISSUE WITH A COBAS U601 URINE ANALYZER. THE SAMPLE IDS AFFECTED WERE (B)(6) WHEN THE ANALYZER WAS IN "SERIAL NUMBER" MODE. THE SAMPLE TUBE WAS NOT DETECTED BY THE U601 ANALYZER BUT WAS DETECTED BY THE U701 ANALYZER. THE RESULTS FROM SAMPLE TUBE ID (B)(6) APPEARED TO BE FROM A SAMPLE TUBE WITH ID (B)(6). THE PATIENT RESULTS DO NOT CORRESPOND TO THE SAMPLE IDS ON THE SAMPLE TUBES. THE OPERATOR WAS MONITORING THE ANALYZER AND NOTICED THAT SOME SAMPLE TUBES WERE NOT DETECTED BY THE U601 ANALYZER AND DELETED THE SAMPLE NUMBERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453674 ↗
• MalfunctionApr 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS U 601 URINE ANALYZER THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: A FALSE NEGATIVE BACTERIA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549744 ↗
• MalfunctionJan 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. TWO RESULTS WERE MISMATCHED BY THE COBAS U 601 URINE ANALYZER. THE EVENTS INVOLVED A TOTAL OF ONE PATIENT WITH THE FOLLOWING: TWO ERRONEOUS RESULT FOR AN UNKNOWN TEST. THE PATIENT'S AGE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278152 ↗