Ortho-Clinical Diagnostics recalls refurbished VITROS 250 Chemistry System (Product Code 6801759) due to potential negative drift in Creatine Kinase (CK) test results. Affected units may produce inaccurate blood test results.
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Ortho-Clinical Diagnostics is recalling refurbished VITROS 250 Chemistry Systems because they might give inaccurate Creatine Kinase (CK) test results. This could lead to incorrect medical diagnoses if used for blood tests.
The refurbished system might produce inaccurate Creatine Kinase (CK) test results, which are used to measure muscle damage and heart health. This could lead to incorrect medical diagnoses if the results are used for patient care.
Lab technicians and healthcare providers who use the VITROS 250 Chemistry System for blood tests may be affected. Patients receiving results from these systems could be at risk of incorrect diagnoses.
Check for the product code 6801759 on the VITROS 250 Chemistry System. The unit was refurbished and sold with a unique device identifier (UDI) #10758750001330.
Look for the product code 6801759 on the VITROS 250 Chemistry System.
The refurbished VITROS 250 Chemistry System may produce inaccurate Creatine Kinase (CK) test results, which could lead to incorrect medical diagnoses.
Check the product code on the system. If it matches 6801759, contact Ortho-Clinical Diagnostics for further instructions.
No, the recall is for potential inaccurate test results, not a physical safety hazard.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1935-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1935-2019 from Ortho-Clinical Diagnostics. 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.
