Ortho-Clinical recalls VITROS XT TBIL-ALKP Slides that may give false low liver values, risking missed liver disease diagnosis. Affected units have specific product codes and expiry dates.
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Ortho-Clinical is recalling VITROS XT TBIL-ALKP Slides because samples with high ALKP levels can cause the system to report falsely low liver values, potentially missing liver disease diagnosis. This affects lab tests that use these slides.
The slides might not detect substrate depletion when high ALKP levels are present. This causes the system to report lower liver values than actual, which could delay or miss liver disease diagnosis.
Lab users who run tests with these slides may be affected. Patients with liver disease could miss diagnosis if the test results are inaccurate.
Check for product codes 6844296 with UDI 10758750031801. The slides have specific expiry dates: July 2023 to January 2025.
Look for product code 6844296 and UDI 10758750031801 on the slides.
No, the recall does not require stopping use. The slides may still be used but could give inaccurate results.
Check the product code and expiry dates. If affected, contact Ortho-Clinical for guidance.
The recall describes a risk of missed diagnosis, not physical injury. This is a low-risk issue for lab users.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2623-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2623-2023 from Ortho-Clinical. 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.
