Tina-quant D-Dimer 3001245322Recalls & reported problems
Roche Diagnostics GmbH · Class 2
All models of Tina-quant D-Dimer (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630914593), received between Aug 26, 2021 and May 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Test Results” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Oct 3, 2023Open, Classified
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Z-0352-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- High Test Results1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Low Test Results
THERE WAS AN ALLEGATION OF QUESTIONABLE LOW TINA-QUANT D-DIMER RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM WHEN COMPARED TO A REFERENCE LABORATORY. OF THE DATA PROVIDED, THE RESULT FOR ONE SAMPLE WERE A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 0.35 (<0.5) G/ML. THE RESULT FROM A REFERENCE LABORATORY USING A STA COMPACT MAX ANALYZER WAS 2.00 G/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134911 ↗MalfunctionAug 26, 2021High Test Results; High Test Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE D-DI TINA-QUANT D-DIMER RESULTS FOR ONE PATIENT SAMPLE WITH THE COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 4677 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE REPEATED RESULT WAS 4550 NG/ML. THE PHYSICIAN QUESTIONED THIS RESULT AS WELL. THE CUSTOMER SENT THE SAMPLE TO THREE DIFFERENT LABORATORIES FOR REPEAT TESTING. THE FIRST LABORATORY TESTED THE SAMPLE WITH A COBAS C501 USING A REAGENT FROM A THIRD PARTY AND RECEIVED A RESULT OF 474 NG/ML (CUTOFF < 250 DDU NG/ML). THE SECOND LABORATORY TESTED THE SAMPLE WITH A COBAS C502 USING A ROCHE REAGENT AND RECEIVED A RESULT OF 5.1 MG/L (CUTOFF 0.5 FEU MG/L). ON (B)(6) 2021, THE THIRD LABORATORY TESTED THE SAMPLE WITH A SIEMENS ANALYZER AND RECEIVED A RESULT OF 0.9 FEU MG/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12369463 ↗
Other FIBRIN SPLIT PRODUCTS devices
- Tina-quant D-Dimer 08105618190Roche Diagnostics GmbH · FIBRIN SPLIT PRODUCTS1 recall0 reports
- AU OSR60135Beckman Coulter, Inc. · Fibrin Split Products1 report
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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