Tinaquant Lipoprotein a Gen.2 5852625190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630929962), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Non Reproducible Results; Non Reproducible Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH TINA-QUANT LIPOPROTEIN (A) GEN.2 (LPA2) ASSAY ON A COBAS C503 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT ANALYTICAL UNIT. SAMPLE 2 AND SAMPLE 3 WERE PLASMA SAMPLES. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 86 MG/DL (ACCOMPANIED BY A DATA FLAG AND TESTED ON THE ORIGINAL C503). 1ST REPEAT RESULT: 31 MG/DL (TESTED ON THE ORIGINAL C503 WITH 3 TIMES DILUTION). 2ND AND 3RD REPEAT RESULTS WERE BOTH 19 MG/DL (TESTED ON ANOTHER ANALYTICAL UNIT). 4TH AND 5TH REPEAT RESULTS WERE BOTH 19 MG/DL (TESTED ON THE ORIGINAL C503). SAMPLE 2 (PATIENT 2) WAS TESTED ON (B)(6)2024: INITIAL RESULT: 39 MG/DL (TESTED ON THE ORIGINAL C503). 1ST REPEAT RESULT: 49 MG/DL (TESTED ON THE ORIGINAL C503). 2ND AND 3RD REPEAT RESULTS WERE BOTH 16 MG/DL (TESTED ON ANOTHER ANALYTICAL UNIT). 4TH REPEAT RESULT: 16 MG/DL (TESTED ON THE ORIGINAL C503). 5TH REPEAT RESULT: 17 MG/DL (TESTED ON THE ORIGINAL C503). SAMPLE 3 (PATIENT 3) WAS TESTED ON (B)(6)2024: INITIAL RESULT: 55 MG/DL (TESTED ON THE ORIGINAL C503). 1ST REPEAT RESULT: 42 MG/DL (TESTED ON THE ORIGINAL C503). 2ND REPEAT RESULT: 28 MG/DL (TESTED ON ANOTHER ANALYTICAL UNIT). 3RD RE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20928443 ↗
Other LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL devices
- Lp (a) LP3403Randox Laboratories Limited · Lipoprotein, Low-Density, Antigen, Antiserum, Control1 recall0 reports
- Lp (a) LP2757Randox Laboratories Limited · Lipoprotein, Low-Density, Antigen, Antiserum, Control1 recall0 reports
- Tina-quant Lipoprotein (a) Gen.2 08106126190Roche Diagnostics GmbH · LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL28 reports
- Tinaquant Lipoprotein a Gen.2 5852633190Roche Diagnostics GmbH · LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page