Tina-quant IgA Gen.2 08057885190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336121313), received between Aug 9, 2021 and Dec 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K040435); 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 16, 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.

• MalfunctionDec 4, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT IGA GEN.2 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN IGA VALUE OF 2.0 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 29.04 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843740 ↗
• MalfunctionJul 23, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT IGA GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7682 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING A DECREASED SAMPLE VOLUME AND THE RESULT WAS 7646 MG/DL WITH A DATA FLAG. THE OPERATOR QUESTIONED THE RESULTS, AS THEY WERE ABOVE THE ASSAY MEASURING RANGE, AND THE SAMPLE WAS REPEATED. ON (B)(6) 2024 THE REPEATED RESULT WITH A 1:3 DILUTION WAS 24.6 MG/DL. THE SAMPLE WAS REPEATED AND THE RESULT WAS 28971 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING A DECREASED SAMPLE VOLUME AND THE RESULT WAS 7443 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED USING AN INCREASED SAMPLE VOLUME AND THE RESULT WAS 5.16 MG/DL. ON (B)(6) 2024 THE SAMPLE WAS REPEATED WITH A MANUAL DILUTION (1:2 RATIO) AND THE RESULT WAS 8884 MG/DL WITH A DATA FLAG. THE RAW VALUE, THAT WAS MEASURED WHEN USING A DECREASED SAMPLE VOLUME, WAS 3777 MG/DL. THE FINAL VALUE WHEN APPLYING THE DILUTION FACTOR WAS 7554 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807374 ↗
• MalfunctionMay 3, 2022Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH IGA-2 TINA-QUANT IGA GEN.2 ON A COBAS PRO C 503 ANALYZER (SERIAL NUMBER (B)(4)). A QUESTIONABLE VALUE FROM THE SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE VALUES DID NOT CORRESPOND TO OTHER LABORATORY FINDINGS OF THE PATIENT AND A HIGH DOSE HOOK EFFECT WAS SUSPECTED. THE SAMPLE WAS INITIALLY TESTED TWICE AND DID NOT GENERATE IGA VALUES, ONLY DATA FLAGS. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 0.167 G/L. THE SAMPLE WAS DILUTED 1:3 BY THE ANALYZER AND REPEATED, RESULTING IN A VALUE OF 0.0758 G/L. THE SAMPLE WAS REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF 0.77 G/L. THE 0.77 G/L VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. OTHER LABORATORY FINDINGS OF THE PATIENT INCLUDE A TOTAL PROTEIN RESULT OF 128 G/L AND AN IGA "M GRADIENT" ELECTROPHORESIS RESULT (CALCULATED IGA) OF 80 G/L. IMMUNOFIXATION OF THE PATIENT SAMPLE CONFIRMED THE PRESENCE OF IGA LAMBDA. REFER TO THE ATTACHMENT FOR ELECTROPHORESIS AND IMMUNOFIXATION RESULTS. BASED ON THESE FINDINGS, MULTIPLE MYELOMA TYPE IGA LAMBDA OF THE PATIENT IS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269793 ↗
• MalfunctionAug 9, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT IGA GEN.2 (IGA-2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RUN OF THE PATIENT SAMPLE FROM THE PRIMARY TUBE PRODUCED AN ALARM WITH NO NUMERIC RESULT. THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED IN A CUP AND ANOTHER ALARM WAS RECEIVED WITH NO NUMERIC RESULT. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.827 G/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2021 THE DOCTOR COMPLAINED THAT THE LOW RESULT WAS NOT PLAUSIBLE. THIS WAS ALSO CONFIRMED BY THE RESULTS FROM ELECTROPHORESIS AND IMMUNOFIXATION TESTING. ON (B)(6) 2021 THE CUSTOMER REPEATED THE ORIGINAL SAMPLE TWICE WITH RESULTS OF 96.4 G/L WITH A DATA FLAG AND 97.8 G/L WITH A DATA FLAG. ON (B)(6) 2021 A NEW SAMPLE WAS OBTAINED AND THE INITIAL RESULT WAS 94.7 G/L WITH A DATA FLAG. THIS SAMPLE WAS REPEATED WITH A RESULT OF 65.4 G/L WITH A DATA FLAG. ON (B)(6) 2021 THE ORIGINAL SAMPLE WAS RUN AGAIN AND THE RESULT WAS 463 G/L WITH A DATA FLAG AND THE REPEAT WAS 67.0 G/L WITH A DATA FLAG. THIS SAMPLE WAS ALSO RUN BY A 1:10 DILUTION WITH CALCULATED RESULTS OF 62.8 G/L AND 66.0 G/L. THE CUSTOMER STATED BOTH SAMPLES WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297557 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040435. One submission often covers many models, so check the product and lot details in each record.

• Z-1979-2019 · Jun 3, 2019 · Terminated
  The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrical