Tinaquant Albumin Gen2 5167043190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630924899), received between Feb 22, 2024 and Sep 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K101203); they may or may not involve this specific model.

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 4 most recent of 4 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101203. One submission often covers many models, so check the product and lot details in each record.

• Z-1124-2019 · Dec 14, 2018 · Terminated
  COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04