Ortho-Clinical Diagnostics recalls VITROS Sodium Slides (Catalog # 837 9034) due to potential for positively biased results. Affected units have specific UDI and expiry dates.
Potential for positively biased results
Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides (Catalog # 837 9034) because they may produce test results that are too high. This could lead to incorrect health decisions if used without replacement.
The slides may cause test results to be too high, leading to potential misdiagnosis. This happens due to a manufacturing issue that affects the accuracy of sodium measurements in blood samples.
Healthcare professionals and labs using the VITROS Sodium Slides for blood tests. Those most at risk are users who rely on these slides for critical diagnostic tests.
Check for Catalog # 837 9034 on the slides. The Unique Device Identifier (UDI) is 10758750004812. These slides were sold between November 2018 and November 2019.
Look for Catalog # 837 9034 and UDI 10758750004812 on the slides.
The slides may produce test results that are too high, leading to potential misdiagnosis.
Check the Catalog # and UDI to confirm if you have affected units. Contact Ortho-Clinical Diagnostics for guidance.
The recall is for potential inaccurate test results, not physical harm. This is a low-risk issue requiring replacement.
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-3280-2018 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-3280-2018 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.
