Tina-quant D-DimerRecalls & reported problems across all models

We found 2 models of Tina-quant D-Dimer by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Tina-quant D-Dimer recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Tina-quant D-Dimer problems

Tina-quant D-Dimer models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tina-quant D-Dimer 3001245322

  FIBRIN SPLIT PRODUCTS
  1 recall2 reports
• Tina-quant D-Dimer 08105618190

  FIBRIN SPLIT PRODUCTS
  1 recall0 reports

Recent Tina-quant D-Dimer adverse event reports

The 2 most recent reports across all models, 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 ↗

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