Ortho-Clinical Diagnostics recalls VITROS XT ALKP Slides that may give false low liver disease results. Affected units have specific product codes and expiry dates. Stop using if you have these slides to avoid missed diagnoses.
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 Diagnostics is recalling VITROS XT ALKP Slides that may give false low liver disease results. This could lead to missed or delayed diagnosis of liver disease if the slides are used without the system detecting a substrate depletion error.
The slides may not show a substrate depletion error when high ALKP levels or interfering substances are present. This causes the system to report lower than actual liver disease values, potentially missing critical diagnoses.
People who use VITROS ALKP Slides for liver disease testing are affected. Those with specific product codes and expiry dates listed in the recall are most at risk.
Check for product codes: 1053180 UDI:(10758750008346) with generation numbers 21-30 and specific expiry dates listed in the recall.
Identify the product code and generation number on the slide to confirm if it's affected.
If you have the affected product codes, stop using the slides immediately to avoid false low liver disease results.
Affected product codes include 1053180 UDI:(10758750008346) with generation numbers 21-30 and specific expiry dates listed in the recall.
The slides may not show a substrate depletion error when high ALKP levels or interfering substances are present, leading to false low liver disease results.
The recall does not specify a return process; you should stop using affected slides to avoid false results.
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-2624-2023 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2624-2023 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.
