Ortho-Clinical Diagnostics recalls VITROS Cl- Slides (Product Code 68:4471) due to triglyceride interference at lower concentrations than claimed, affecting chloride tests. This may lead to inaccurate results in medical diagnostics.
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 684 4471) because they can give inaccurate chloride test results at triglyceride levels below 800mg/dL, which is lower than the claimed safe level. This could lead to incorrect medical diagnoses for conditions like cystic fibrosis and diabetic acidosis.
The slides may show interference with chloride measurements when triglyceride levels are between 600-800mg/dL, causing inaccurate test results. This could lead to incorrect diagnoses for conditions like cystic fibrosis and diabetic acidosis if the slides are used without proper validation.
Healthcare providers using VITROS Cl- Slides for in vitro diagnostic tests are most at risk, particularly those testing patients with high triglyceride levels.
Check for VITROS Cl- Slides with Product Code 684 4471 used in VITROS 250/350/5,1 FS, 4600, or 5600 Chemistry Systems. These slides are intended for in vitro diagnostic use only.
Verify the product code on the slide packaging to confirm it is 684 4471.
The slides may show interference with chloride measurements at triglyceride levels between 600-800mg/dL, which is lower than the claimed safe level of 800mg/dL.
Inaccurate chloride test results could occur if triglyceride levels are between 600-800mg/dL, potentially leading to incorrect diagnoses for conditions like cystic fibrosis and diabetic acidosis.
Look for VITROS Cl- Slides with Product Code 684 4471 used in VITROS 250/350/5,1 FS, 4600, or 5600 Chemistry Systems.
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-3044-2018 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-3044-2018 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.
