Ortho-Clinical Diagnostics recalls VITROS Cl- Slides (Product Code 844 5207) due to triglyceride interference issues at lower concentrations than claimed, affecting lab tests.
The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.
Ortho-Clinical Diagnostics is recalling VITROS Cl- Slides (Product Code 844 5207) because they may show false results when serum samples have triglycerides below 800mg/dL. This could lead to inaccurate lab test results if used without proper testing protocols.
The slides may show interference (false results) when serum samples contain triglycerides around 600mg/dL, but the product claims no interference below 800mg/dL. This means some samples could give inaccurate chloride measurements.
Lab users who test serum samples with triglyceride levels between 600-800mg/dL may be affected. Patients with high triglycerides could see inaccurate chloride test results if their samples are processed with these slides.
Check for VITROS Cl- Slides with Product Code 844 5207. These are used in lab tests for chloride concentration with VITROS 250/350/5,1 FS, 4600 Chemistry Systems, and VITROS 5600 Integrated Systems.
Look for Product Code 844 5207 on the slides to confirm they are affected.
The slides may show interference (false results) when serum samples have triglycerides around 600mg/dL, but the product claims no interference below 800mg/dL.
Check the product code; if it's 844 5207, stop using them for serum tests until a corrected version is available.
This could lead to inaccurate chloride test results for samples with triglycerides between 600-800mg/dL, but the risk is low and only affects specific lab tests.
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-3043-2018 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-3043-2018 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.
