Thermo Scientific recalls specific models of cardiac control devices due to vial-to-vial variability in high-sensitivity Troponin I assays, potentially delaying patient results.
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
Thermo Scientific is recalling certain cardiac control devices because they cause inconsistent results with high-sensitivity Troponin I tests, which could delay patient diagnosis. This issue affects lab equipment used in medical testing.
The devices show inconsistent performance when used with high-sensitivity Troponin I assays, leading to potential delays in patient results. This variability could affect the accuracy of cardiac tests and impact timely medical decisions.
Lab technicians and medical facilities using the recalled models may be affected. Those performing high-sensitivity Troponin I tests are most at risk of delayed patient results.
Check for model numbers OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, or OCRD-UL on the device. The product was sold with specific expiration dates in 2027.
Identify the model number on the device to confirm if it is one of the recalled models: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, or OCRD-UL.
The firm received complaints about vial-to-vial variability when using the control with high sensitivity Troponin I assays, which may lead to delays in patient results.
The affected models are OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, and OCRD-UL.
Check the model number on the device; if it matches OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, or OCRD-UL, it is affected.
We’ve drafted a message you can send Thermo Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0415-2026 — Thermo Scientific Thermo Scientific Hello, I own a Thermo Scientific that is covered by recall Z-0415-2026 from Thermo Scientific. 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.
