Ortho-Clinical Diagnostics recalls VITROS 350 Chemistry System (Product Code 6802153) due to potential negative drift in Creatine Kinase (CK) test results when used with VITROS 250 and 350 systems. 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 VITROS 350 Chemistry System units (Product Code 6802153) because they may cause inaccurate Creatine Kinase (CK) test results when used with VITROS 250 or 350 systems. This could lead to incorrect medical diagnoses if the tests are used for critical health assessments.
The VITROS 350 system may produce negative drift in Creatine Kinase (CK) test results when used with VITROS 250 or 350 systems. This means test results could be less accurate over time, potentially leading to incorrect medical diagnoses if the tests are used for critical health assessments.
Healthcare facilities using the VITROS 350 Chemistry System for clinical testing are likely affected. Patients receiving tests that rely on this system may be at risk of inaccurate results.
Check for the Product Code 6802153 on the VITROS 350 Chemistry System. The system was sold with the UDI # 10758750002054 for clinical testing on serum, urine, and cerebral spinal fluid.
Look for Product Code 6802153 on the VITROS 350 Chemistry System.
The VITROS 350 Chemistry System may cause negative drift in Creatine Kinase (CK) test results when used with VITROS 250 or 350 systems, potentially leading to inaccurate medical diagnoses.
The official recall notice does not specify actions for healthcare facilities beyond checking the product code.
The recall is for potential inaccurate test results, not a physical safety hazard like fire or injury.
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-1936-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1936-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
