Roche Tina-quant D-Dimer Test System Recall: Elevated Results with Li-heparin Plasma
Roche recalls Tina-quant D-Dimer Test System with material numbers 03001245322 and others due to elevated results when using Li-heparin plasma samples. Affected units include specific cobas and Integra models.
Lower-risk recall
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Contact the company
What happened, in plain English
Roche is recalling its Tina-quant D-Dimer Test System because it can give higher results when using Li-heparin plasma samples compared to citrated plasma. This could lead to inaccurate test results if the wrong plasma type is used. Read more at govinfonow.com/recall/57180-roche-tina-quant-d-dimer-test-system-recall-elevated-results.
Source Summary by GovInfoNow · govinfonow.com/recall/57180-roche-tina-quant-d-dimer-test-system-recall-elevated-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0352-2024
Cite this page
“Roche Tina-quant D-Dimer Test System Recall: Elevated Results with Li-heparin Plasma.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57180-roche-tina-quant-d-dimer-test-system-recall-elevated-results. Based on FDA recall #Z-0352-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0352-2024%22&limit=1).
Why it’s dangerous
The test system may produce elevated results when blood samples are processed with Li-heparin plasma instead of citrated plasma. This could cause inaccurate test results, potentially leading to incorrect medical decisions.
Who’s affected
Users of the Tina-quant D-Dimer Test System with material numbers 03001245322 and others are affected. Laboratory staff and healthcare providers who perform blood tests are most at risk.
How to tell if you have this one
Check for material numbers 03001245322, 08105618190, or UDI codes 04015630914593 and 07613336133651 on the test system. The affected units include specific cobas and Integra models.
- Brand
Roche- Category
Medical device
What to do — step by step
Check Product Details
Look for material numbers 03001245322, 08105618190, or UDI codes 04015630914593 and 07613336133651 on the test system.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this test system?
No, the recall does not require stopping use; it only requires checking product details to ensure you have an affected unit.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0352-2024 (October 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0352-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.