Tinaquant Albumin Gen2Recalls & reported problems across all models

We found 2 models of Tinaquant Albumin Gen2 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2018 and Sep 16, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tinaquant Albumin Gen2 problems

Tinaquant Albumin Gen2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tinaquant Albumin Gen2 4469658190

  INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
  18 reports
• Tinaquant Albumin Gen2 5167043190

  ALBUMIN, ANTIGEN, ANTISERUM, CONTROL
  4 reports

Recent Tinaquant Albumin Gen2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Test Results

  There was an allegation of questionable Tina-quant Albumin Gen.2 results for 1 patient sample on a cobas 8000 cobas c 701 module.Initial result: 80.7 mg/LThe sample was repeated on another module, and the results were 27.8 mg/L and 27.8 mg/L.The sample was repeated on the same module as the initial result, and the result was 31.2 mg/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792415 ↗
• MalfunctionMar 19, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS <2.6 MG/L. THE REPEAT RESULT WAS 3.5 MG/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 301 MG/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED WITH A RESULT OF 36.1 MG/L. THE SAMPLE WAS REPEATED FURTHER WITH RESULTS OF <0.9 MG/L, < 0.9 MG/L, <0.7 MG/L AND < 2.9 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641016 ↗
• MalfunctionJan 8, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS INTEGRA 400 PLUS W/O ISE. THE INITIAL RESULT WAS 247.4 MG/L. THE REPEAT RESULT WAS 6.6 MG/L. THE REPEAT RESULT WAS DEEMED CORRECT BASED ON THE PATIENT'S MEDICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005357 ↗
• MalfunctionAug 15, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH TINA-QUANTALBUMIN GEN.2 (ALBT2) ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1: THE RESULTS RANGED FROM 2.8 G/DL TO 3.4 G/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS ANALYZER, RESULTING IN THE SAME VALUE RANGE. SAMPLE 2: THE RESULTS RANGED FROM 3 G/DL TO 3.6 G/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS ANALYZER, RESULTING IN THE SAME VALUE RANGE. NO EXACT VALUES WERE PROVIDED. THE RESULTS' RANGE WAS FROM 0.6 G/DL TO 0.7 G/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817377 ↗
• MalfunctionJul 22, 2025Low Test Results; Infusion or Flow Problem; Low Test Results; Infusion or Flow Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 FOR URINE SAMPLES FROM ONE PATIENT USING A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS <12 MG/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 143 MG/L. THE SECOND AND THIRD REPEAT RESULTS WERE 44 MG/L AND 83 MG/L. THE FIRST REPEAT RESULT WAS QUESTIONED AS IT WAS CONSIDERED TOO HIGH WHICH TRIGGERED THE FURTHER REPEAT TESTING OF THE SAMPLE. NONE OF THE RESULTS WERE REPORTED OUT. IT IS UNKNOWN WHICH RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563902 ↗
• MalfunctionJun 30, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. PATIENT 1'S INITIAL RESULT WAS 0.7 G/L, THE FIRST REPEAT RESULT WAS 24.1 G/L, AND THE SECOND REPEAT RESULT WAS 23.1 G/L. PATIENT 2'S INITIAL RESULT WAS 0.8 G/L, THE FIRST REPEAT RESULT WAS 48.3 G/L, AND THE SECOND REPEAT RESULT WAS 47.0 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357363 ↗
• MalfunctionJan 6, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT CEREBROSPINAL FLUID SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 ON TWO COBAS 8000 C702 MODULE ANALYZERS. THE SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 378 MG/L WHEN TESTED ON THE FIRST C 702 ANALYZER. THE SAMPLE WAS REPEATED ON THE SECOND C 702 ANALYZER, RESULTING IN A VALUE OF 225 MG/L. THE 225 MG/L VALUE WAS REPORTED TO THE PHYSICIANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085254 ↗
• MalfunctionDec 4, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT URINE SAMPLES TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 8000 C 502 MODULE. PATIENT 1 INITIAL RESULT WAS 27.3 MG/L. THE REPEAT RESULT WAS 0.5 MG/L. PATIENT 2 INITIAL RESULT WAS 191.3 MG/L. THE REPEAT RESULT WAS 12.0 MG/L. IT IS NOT KNOWN WHICH RESULTS WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844122 ↗
• MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 RESULTS FROM THE COBAS 6000 C 501 MODULE. THE CUSTOMER RECEIVED THE SAMPLE FROM A SISTER SITE FOR CORRELATION. THE CUSTOMER'S INITIAL RESULT DID NOT CORRELATE WITH THE SISTER SITE'S RESULT. SPECIFIC DATA FROM THE SISTER SITE WAS NOT PROVIDED. THE INITIAL RESULT WAS <1 MG/DL. THE REPEAT RESULT WAS 21.7 MG/DL. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT AND DID NOT PROVIDE INFORMATION ABOUT WHICH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953846 ↗
• MalfunctionMar 26, 2024Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 32.500 MG/L AND IT REPEATED AS 11.900 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980530 ↗
• MalfunctionFeb 22, 2024Device Alarm System; Signal Artifact/Noise; Device Alarm System; Signal Artifact/Noise

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALBUMIN GEN.2 (ALBT2) RESULTS FROM TWO URINE PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER STATED THAT THE INITIAL TEST RESULTS WERE OCCASIONALLY LOWER THAN THE TRUE RESULT AND THAT THE PATIENT SAMPLES WERE NOT AUTOMATICALLY RERUN BECAUSE THE PROZONE CHECK CRITERIA WERE NOT MET. THE REPORTER STATED THAT THE INCORRECT RESULTS WERE REPORTED AND THAT RESULTS FROM RERUNS USING DILUTED PATIENT SAMPLES WERE AGAIN REPORTED TO THE CLINICAL AND PATIENT DEPARTMENTS. SAMPLE 1: ON (B)(6) 2024: THE INITIAL RESULT WAS 36.8 MG/L. THE FIRST REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:20 DILUTION WAS 7000 MG/L. ON (B)(6) 2024: THE SECOND REPEAT RESULT WAS 26.4 MG/L WITH AN INVALIDATING DATA FLAG. THE THIRD REPEAT RESULT WAS 40.7 MG/L WITH AN INVALIDATING DATA FLAG. THE FOURTH REPEAT RESULT WAS 30.6 MG/L WITH AN INVALIDATING DATA FLAG. THE FIFTH REPEAT RESULT WAS 47.7 MG/L WITH AN INVALIDATING DATA FLAG. SAMPLE 2: THE REPORTER STATED THAT THE URINE PATIENT SAMPLE WAS SEPARATED INTO INDIVIDUAL HITACHI CUPS. THE REPORTER WAS NOT ABLE TO STATE WHICH RESULTS WERE FROM DILUTED PATIENT SAMPLES. ON (B)(6) 2024: THE INITIAL RESULT WAS 95.9 WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758468 ↗
• MalfunctionSep 28, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALB) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS VALIDATED BY THE LABORATORY INFORMATION SYSTEM (LIS) OF THE HOSPITAL. IT WAS POSSIBLE THAT IT WAS VIEWED BY THE PHYSICIAN. THE REPORTER WAS SUSPICIOUS OF THE LOW RESULT WHICH PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE REPORTER RERAN THE PATIENT SAMPLE ON THE MODULE AND THEIR OTHER 502 MODULE. THEY PERFORMED MAINTENANCE ON THE REPORTED MODULE BEFORE RERUNNING THE PATIENT SAMPLE. THE INITIAL RESULT FROM THE MODULE WAS 17.5 G/L. THE FIRST REPEAT RESULT FROM THE OTHER MODULE WAS 27.1 G/L. THE SECOND REPEAT RESULT FROM THE OTHER MODULE WAS 27.7 G/L. THE THIRD REPEAT RESULT FROM THE MODULE WAS 29.3 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836363 ↗
• MalfunctionDec 6, 2022Low Test Results; Low Readings; Low Test Results; Low Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 324.8 MG/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF < 0.7 MG/L WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF < 0.8 MG/L WITH A DATA FLAG. THE MICROALBUMIN REAGENT LOT NUMBER WAS 65268801. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926561 ↗
• MalfunctionDec 5, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT URINE SAMPLES TESTED FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS 6000 C (501) MODULE. PATIENT 1 INITIAL RESULT WAS 63.3 MG/L. THIS RESULT WAS NOT CONSISTENT WITH OTHER RESULTS FOR THE SAMPLE SO THE LABORATORY REPEATED THE SAMPLE ON A DIFFERENT ANALYZER (METHOD UNKNOWN) AND THE RESULT WAS "NORMAL." ON (B)(6) 2022 THE SAMPLE WAS REPEATED TWICE ON THE C501 MODULE WITH RESULTS OF 0.3 MG/L WITH A DATA FLAG. ANOTHER RESULT FROM THE SAMPLE WAS PROVIDED OF 20.4 MG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 INITIAL RESULT WAS 23 MG/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 14 MG/L AND 22 MG/L. IT IS NOT CLEAR WHICH RESULTS ARE BELIEVED TO BE CORRECT. THE ALBT2 REAGENT LOT NUMBER IS 59240101 WITH AN EXPIRATION DATE OF 30-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914798 ↗
• MalfunctionNov 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH PATIENT SAMPLE RECOVERY FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 ON THE COBAS 6000 C (501) MODULE. THE FIELD SERVICE ENGINEER HAD BEEN OUT TWICE TO ADDRESS THE ISSUE AND ALL PROBES WERE CHANGED ON ONE OF THE VISITS. THE CUSTOMER STATED THE ISSUE SEEMED TO START AFTER USING A NEW LOT OF CALIBRATOR. DATA WAS PROVIDED FOR 5 PATIENT SAMPLES TESTED FOR MICROALBUMIN. THE INITIAL VALUES WERE MEASURED EITHER ON (B)(6) 2022 OR(B)(6)2022 AND WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON (B)(6)2022. THE CUSTOMER DID NOT KNOW WHICH VALUES WERE CORRECT. THE CUSTOMER STATED THAT THE FIRST TWO SAMPLES WERE TESTED PRIOR TO THE VISITS FROM THE ENGINEER. SAMPLES 3-5 WERE TESTED AFTER THE VISITS FROM THE ENGINEER. THE FIRST SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF < 12 MG/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 22 MG/L. THE SECOND SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 106.3 MG/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 22.1 MG/L. THE THIRD SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF < 12 MG/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831281 ↗

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