Tina-quant Myoglobin Gen.2 08252629190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336147863), received between Jul 10, 2024 and Jul 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 other recall cover devices cleared under the same FDA submission (K061683); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS MYOGLOBIN (MYO) AND TINA-QUANT MYOGLOBIN GEN.2 TEST RESULTS FROM FIVE PATIENT SAMPLES (THREE FROM THE SAME PATIENT) TESTED ON THE COBAS E 801 ANALYTICAL UNIT AND THE COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS MYOGLOBIN (MYO) ASSAY. PATIENT SAMPLE 1A ON (B)(6) 2024: THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE FROM THE ANALYZER WAS <21 UG/L. THIS RESULT DID NOT CORRESPOND WITH THE CK RESULT OF 53.9 UKAT/L WITH A DATA FLAG (UNDILUTED) AND 55.9 UKAT/L (WITH DILUTION) PROMPTING THE DILUTION OF THE PATIENT SAMPLE. THE FIRST REPEAT RESULT AT 10X DILUTION FROM THE ANALYZER WAS 210 UG/L WITH A DATA FLAG. THE SECOND REPEAT RESULT AT 20X DILUTION FROM THE ANALYZER WAS 420 UG/L WITH A DATA FLAG. THE THIRD REPEAT RESULT AT 100X DILUTION FROM THE ANALYZER WAS 2393 UG/L. THE REPEAT RESULT AT 900X DILUTION FROM THE ANALYZER WAS > 20,000 UG/L THE RESULT FROM THE OTHER LABORATORY THAT USES THE CHEMILUMINESCENCE IMMUNOASSAY (CLIA) METHOD WAS 59.7 NG/ML. THIS RESULT CORRESPONDS WITH THE PATIENT¿S CK-MB RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714099 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061683. One submission often covers many models, so check the product and lot details in each record.

• Z-2445-2019 · Jul 2, 2019 · Terminated
  The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated