Ortho-Clinical Diagnostics recalls VITROS CREA Slides (Product Code 680 2584) due to inaccurate creatinine measurements in serum and urine. The slides may give false low results affecting health assessments.
The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.
Ortho-Clinical Diagnostics is recalling VITROS CREA Slides (Product Code 680 2584) because they don't measure creatinine levels accurately enough for serum and urine samples. This could lead to incorrect health assessments if used in diagnostic tests.
The slides do not meet the required accuracy standards for measuring creatinine in serum and urine. This means they might give false low results, potentially leading to incorrect health assessments if used in diagnostic tests.
People using VITROS CREA Slides for creatinine testing in labs or clinics. Those with kidney function tests may be at risk of inaccurate results.
Check for Product Code 680 2584 on VITROS CREA Slides. These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Look for Product Code 680 2584 on the slides to confirm if they are affected.
The slides do not meet the required accuracy standards for measuring creatinine in serum and urine, which could lead to false low results.
Using these slides may result in inaccurate creatinine measurements, potentially affecting health assessments if used in diagnostic tests.
Check for Product Code 680 2584 on VITROS CREA Slides used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
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-3193-2018 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-3193-2018 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.
