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.
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
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.
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.
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.
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.
Look for material numbers 03001245322, 08105618190, or UDI codes 04015630914593 and 07613336133651 on the test system.
The test system may produce elevated results when using Li-heparin plasma samples compared to citrated plasma, which could lead to inaccurate test results.
Material numbers 03001245322, 08105618190, and UDI codes 04015630914593 and 07613336133651 are affected.
No, the recall does not require stopping use; it only requires checking product details to ensure you have an affected unit.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0352-2024 — Roche Roche Hello, I own a Roche that is covered by recall Z-0352-2024 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
