Ortho-Clinical Diagnostics recalls VITROS Na+ Slides (Catalog 8379034) due to possible inaccurate sodium test results. Affected lots may produce biased patient and quality control results.
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides (Catalog Number 8379034) because some lots may give inaccurate sodium test results. This could lead to incorrect patient diagnoses or quality control failures in lab testing.
The affected lot of VITROS Na+ Slides may produce test results that are too high or too low. This imprecision could lead to incorrect patient diagnoses or quality control failures in laboratory testing.
Lab users who purchased the VITROS Na+ Slides (Catalog 8379034) for in vitro diagnostics are affected. Healthcare professionals and labs using these slides for sodium testing are most at risk.
Check for the catalog number 8379034 on the VITROS Na+ Slides. The affected lot number is 4221-0998-3223. These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems.
Look for the lot number 4221-0998-3223 on the VITROS Na+ Slides packaging.
The affected lot may produce test results that are too high or too low, leading to inaccurate sodium measurements.
The recall record does not specify a remedy, so contact Ortho-Clinical Diagnostics for guidance.
These slides are 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-0992-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0992-2019 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.
