Tinaquant Lipoprotein a Gen.2 5852633190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630930586), received between Feb 21, 2025 and Mar 24, 2026 — classified as 2 malfunctions.

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

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.

• MalfunctionMar 24, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 236 NMOL/L. THIS RESULT WAS QUESTIONED BY THE PHYSICIAN, AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 248.0 NMOL/L, ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE REPEAT RESULT WAS 1213.5 NMOL/L. THE SAMPLE WAS REPEATED WITH A 1:3 DILUTION, AND THE RESULT WAS 1206.0 NMOL/L, ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:5 DILUTION, AND THE RESULT WAS 1431.5 NMOL/L, ACCOMPANIED BY AN INVALIDATING FLAG. THE SAMPLE WAS REPEATED WITH A 1:20 DILUTION, AND THE RESULT WAS 951.1 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681101 ↗
• MalfunctionFeb 21, 2025Low Test Results; Chemical Problem; Non Reproducible Results; Low Test Results; Chemical Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT LIPOPROTEIN (A) GEN.2 RESULT FROM THE COBAS 8000 ISE 1800 MODULE. THE INITIAL RESULT WAS 230 NMOL/L, AND THE REPEAT RESULT ON A SIEMENS ANALYZER WAS 579 NMOL/L. THERE WAS ANOTHER TEST COMPLETED ON THE C 701 FROM THE SAME SAMPLE WITH DILUTION THAT GAVE A RESULT OF > TEST. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE IT DID NOT MATCH THE PREVIOUS RESULTS. THE RESULTS OF 579 NMOL/L MATCHED WITH PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433840 ↗