Ortho-Clinical Diagnostics recalls VITROS 250AT Chemistry System (Product Code 1758143) due to potential negative drift in Creatine Kinase (CK) test results. Affected units may produce inaccurate test results.
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Ortho-Clinical Diagnostics is recalling its VITROS 250AT Chemistry System (Product Code 1758143) because it may cause inaccurate Creatine Kinase (CK) test results. This could lead to incorrect medical diagnoses if used in clinical settings.
The VITROS 250AT system may produce negative drift in Creatine Kinase (CK) test results, meaning test values could become less accurate over time. This could lead to incorrect medical diagnoses if the system is used for critical health assessments.
Healthcare facilities and labs that use the VITROS 250AT Chemistry System for clinical testing are likely affected. Patients receiving tests using this system may be at risk of inaccurate results.
Check for the product code 1758143 on the VITROS 250AT Chemistry System. The system was sold for clinical use in laboratories handling blood tests.
Verify if your VITROS 250AT Chemistry System has the product code 1758143.
The VITROS 250AT system may cause negative drift in Creatine Kinase (CK) test results, potentially leading to inaccurate medical diagnoses.
Check if your system has product code 1758143. If so, contact Ortho-Clinical Diagnostics for guidance.
This recall is for potential inaccurate test results, not a physical safety hazard. The risk is low and does not require immediate action.
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-1934-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1934-2019 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.
