Tinaquant IgA Gen2 3507343190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630919680), received between Oct 14, 2022 and May 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT IGA GEN.2 (IGA) RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE MODULE WAS 356 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 169 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE MODULE WAS 437 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 287 MG/DL. PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE MODULE WAS 348 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 252 MG/DL. PATIENT SAMPLE 4 THE INITIAL RESULT FROM THE MODULE WAS 52 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 151 MG/DL. SOME RESULTS HAD INVALIDATING FLAGS, PROMPTING THE PATIENT SAMPLES TO BE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975791 ↗
• MalfunctionOct 14, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE IGA-2 TINA-QUANT IGA GEN.2 RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS DIFFERENT FROM THE PREVIOUS RESULT OF THE PATIENT FROM 4 DAYS PRIOR. THE INITIAL RESULT WAS 71 MG/DL. THE FIRST REPEAT RESULT WAS 0 MG/DL WITH A DATA FLAG. THE SECOND REPEAT RESULT WAS 3 MG/DL WITH A DATA FLAG. THE THIRD REPEAT RESULT WAS 0 MG/DL WITH A DATA FLAG. THE FOURTH REPEAT RESULT WAS 2 MG/DL WITH A DATA FLAG. THE REPORTER RELEASED A RESULT OF <5 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. THE REAGENT LOT NUMBER IS 58129801 WITH AN EXPIRATION DATE OF 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608084 ↗

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