Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System (Product Code 8132086) 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 the VITROS 250 Chemistry System (Product Code 8132086) because it may produce inaccurate Creatine Kinase (CK) test results. This could lead to incorrect medical diagnoses if the system is used for clinical testing.
The VITROS 250 Chemistry System may produce negative drift in Creatine Kinase (CK) test results, meaning test values could become inaccurate over time. This could lead to incorrect medical diagnoses if the system is used for clinical testing.
Healthcare facilities using the VITROS 250 Chemistry System for clinical testing are likely affected. Patients receiving tests from these systems may be at risk of inaccurate results.
Check for the Product Code 8132086 on the VITROS 250 Chemistry System. The system was sold with the UDI # 10758750004409 for clinical testing on serum, urine, and cerebral spinal fluid.
Verify the Product Code on your VITROS 250 Chemistry System to confirm if it is affected.
The VITROS 250 Chemistry System may produce negative drift in Creatine Kinase (CK) test results, which could lead to inaccurate medical diagnoses.
Check the Product Code on your VITROS 250 Chemistry System to confirm if it is affected. The official recall notice does not specify a remedy.
The recall addresses potential inaccurate test results, not physical safety risks. There is no mention of injury risks in the official notice.
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-1933-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1933-2019 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.
