Tina-quant Albumin Gen.2 08056722190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613336120965), received between Feb 16, 2023 and Sep 18, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026High Test Results

  The initial reporter received questionable Tina-quant Albumin Gen.2 assay results for six patient samples tested on the cobas c 503 analytical unit. The following patient samples with discrepant results were identified from the data provided:On (b)(6)2026, the following patient samples were reported:Sample 1Initial analysis on the reported cobas c 503 unit yielded a total protein result of 5.50 g/dL. Repeat testing on a secondary c 503 unit yielded 4.20 g/dL.Sample 2Initial testing on the reported c 503 unit yielded 5.54 g/dL, and following instrument maintenance/cleaning, the repeat result was 5.90 g/dL. Repeat testing on the secondary c 503 unit yielded 4.10 g/dL.On (b)(6)2026, the following patient samples were reported:Sample 3: Initial analysis yielded 6.27 g/dL, with repeat testing yielding 4.77 g/dL.Sample 4: Initial analysis yielded 6.01 g/dL, with repeat testing yielding 4.61 g/dL.The customer considers the lower results to be correct, given that the samples were obtained from young and healthy individuals.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817040 ↗
• MalfunctionSep 3, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591965 ↗
• MalfunctionJul 1, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH THE TINA-QUANT ALBUMIN GEN.2 ASSAY AND CREATININE ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: MICROALBUMIN = 8.77 MG/DL. CREATININE = 24.80. THE CREATININE UNIT OF MEASURE IS UNKNOWN. THE SAMPLE WAS REPEATED, RESULTING IN THE FOLLOWING VALUES: MICROALBUMIN = 8.74 MG/DL. CREATININE = 18.60. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN A MICROALBUMIN VALUE OF 45.10 MG/DL. THE SAMPLE WAS ALSO DILUTED 1:3 AND REPEATED, RESULTING IN A MICROALBUMIN VALUE OF 19 MG/DL. THE SAMPLE WAS REPEATED TWO MORE TIMES, RESULTING IN MICROALBUMIN VALUES OF 8.68 MG/DL AND 8.43 MG/DL. THE SAMPLE WAS REPEATED USING DECREASED SAMPLE VOLUME, RESULTING IN A MICROALBUMIN VALUE OF 47.2 MG/DL. THE SAMPLE WAS DILUTED 1:11 AND REPEATED ON (B)(6) 2026, RESULTING IN A MICROALBUMIN RESULT OF 47.4 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677014 ↗
• MalfunctionFeb 16, 2026High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL CONDITION FOR MULTIPLE PATIENT SPONTANEOUS URINE SAMPLES TESTED FOR TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER IS QUESTIONING THE ALBT2 RESULTS AS THEY ARE ALLEGEDLY "MUCH HIGHER" THAN THE TOTAL PROTEIN RESULTS. ALL OF THE AFFECTED PATIENTS ARE TAKING ACE INHIBITORS. THE CUSTOMER ALLEGES THE ISSUE ONLY AFFECTS PATIENTS TAKING ACE INHIBITORS. THE FOLLOWING ARE EXAMPLES OF RESULTS FOR 3 PATIENT SAMPLES. PATIENT 1 ALBT2 RESULT WAS 1263 MG/L. THE TOTAL PROTEIN RESULT WAS 1133 MG/L. PATIENT 2 ALBT2 RESULT WAS 1015 MG/L. THE TOTAL PROTEIN RESULT WAS 765 MG/L. PATIENT 3 ALBT2 RESULT WAS 1388 MG/L. THE TOTAL PROTEIN RESULT WAS 1072 MG/L. SERUM CARRYOVER WAS SUSPECTED, AND THE CUSTOMER PERFORMED A TEST WITH URINE SAMPLES. FOR THESE SAMPLES, THE INITIAL RESULTS WERE ACCOMPANIED BY DATA FLAGS; THE REPEAT RESULTS WITH DILUTION WERE LOWER. THE FOLLOWING IS AN EXAMPLE FROM THIS TEST: THE INITIAL ALBT2 RESULT WAS 551 MG/L WITH AN INVALIDATING DATA FLAG. THE REPEAT WITH DILUTION WAS 432 MG/L THE TOTAL PROTEIN RESULT WAS 389 MG/L THE CUSTOMER HAS BEEN PERFORMING URINE ALBUMIN AND URIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343965 ↗
• MalfunctionNov 19, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULT FROM ONE URINE PATIENT SAMPLE TESTED ON TWO COBAS PRO SSU. THE INITIAL RESULT FROM THE FIRST COBAS PRO USING NORMAL VOLUME WAS 324 MG/L. THE REPEAT RESULT FROM THE FIRST COBAS PRO USING DECREASED VOLUME WAS 824 MG/L. THE REPEAT RESULT FROM THE SECOND COBAS PRO USING NORMAL VOLUME WAS 325 MG/L. THE REPEAT RESULT FROM THE SECOND COBAS PRO USING DECREASED VOLUME WAS 824 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597082 ↗
• MalfunctionJul 22, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULT FOR 1 PATIENT URINE SAMPLE TESTED FOR TINA-QUANT ALBUMIN GEN.2 (ALBT2) TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ON A COBAS C 503 ANALYTICAL UNIT. THE 24-HOUR ALBT2 RESULT WAS REPORTEDLY 924 MG/L (RESULT NOT MULTIPLIED BY THE TOTAL DIURESIS). THE 24-HOUR TOTAL PROTEIN RESULT WAS REPORTEDLY 284 MG/L (WHEN MULTIPLIED BY THE TOTAL 24-HOUR DIURESIS VOLUME OF 3500 ML, THE RESULT WAS 994 MG). THE ALBT2 RESULT IS OUTSIDE THE TEST'S MEASUREMENT RANGE OF 3 ¿ 400 MG/L. IT WAS NOTED THAT THE TESTS WERE ACCOMPANIED BY >TEST FLAGS; HOWEVER, THE MEASUREMENT RANGE FOR TOTAL PROTEIN IS 40 ¿ 2000 MG/L. CLARIFICATION ON THE RESULTS AND UNIT OF MEASURE HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THE NEPHROLOGIST QUESTIONED THE ALBT2 RESULT AS THE RESULT SHOULD BE EQUAL TO OR LESS THAN THE TOTAL PROTEIN RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563822 ↗
• MalfunctionMay 28, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 (MIROALBUMIN) RESULTS FOR URINE SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER AND THEN ANOTHER COBAS C 503 ANALYTICAL UNIT. SAMPLE (B)(6) INITIAL RESULT WAS 98.6 MG/L, AND THE REPEAT RESULTS WERE 20.8 MG/L AND 3.3 MG/DL WITH A DATA FLAG (REPORTED AS <12.0 MG/L). SAMPLE (B)(6) INITIAL RESULT WAS 32.4 MG/L, AND THE REPEAT RESULTS WERE 5.28 MG/L WITH A DATA FLAG (REPORTED AS <12.0 MG/L) AND 4.12 MG/L WITH A DATA FLAG (REPORTED AS <12.0 MG/L). THE REPEAT RESULTS FROM THE OTHER ANALYZER WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095314 ↗
• MalfunctionNov 20, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) RESULTS FOR A URINE SAMPLE FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT 2.94 MG/DL (29.4 MG/L) WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 1.64 MG/DL (16.4 MG/L) WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:3 DILUTION AND THE RESULT WAS 2.71 MG/DL (27.1 MG/L) WITH A DATA FLAG. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE FINAL REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735365 ↗
• MalfunctionOct 4, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 ALBUMIN GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS THE RESULTS WERE NOT CONSISTENT WITH THE PATIENTS' CLINICAL PICTURES. ON (B)(6) 2023, SAMPLE 1 HAD AN INITIAL RESULT OF 3.77 G/L. THE REPEAT RESULT WAS 39.9 G/L. ON (B)(6) 2023, SAMPLE 2 HAD AN INITIAL RESULT OF <3 G/L WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 20 G/L AND 20 G/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870013 ↗
• MalfunctionAug 31, 2023High Test Results; Material Integrity Problem; High Test Results; Material Integrity Problem

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT URINE SAMPLE TESTED FOR TINA-QUANT ALBUMIN GEN.2 (ALBT2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 40.1 MG/L. THE REPEAT RESULT WAS LESS THAN 0.583 MG/L WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662097 ↗
• MalfunctionFeb 16, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL ALBUMIN RESULT WAS 71.9 G/L. THE SAMPLE WAS REPEATED FOUR TIMES AND THE RESULTS WERE 45.1 G/L, 44.2 G/L, 44.7 G/L, AND 44.4 G/L. IT IS UNKNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER IS 617156. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387810 ↗

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