Ortho-Clinical Diagnostics recalls VITROS Lipase Slides with potential for false low or high lipase results, risking missed pancreatitis diagnosis. Affected product codes include 1668409 and 8297749.
Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides that may give inaccurate lipase test results. False low levels could miss acute pancreatitis, while false high levels might cause confusion in abdominal pain cases.
The slides may cause test results to be 46% lower or 86% higher than actual lipase levels. False low results could miss pancreatitis, while false high results might delay proper diagnosis for abdominal pain.
Lab users and healthcare professionals who test lipase levels with these specific slides. Patients with abdominal pain or suspected pancreatitis are at risk of delayed diagnosis.
Check for product codes 1668409 (60 slides per cartridge) or 8297749 (18 slides per cartridge). Affected lots are listed in the description: 5905-3348-1557 for code 1668409 and 5905-3348-2899 for code 8297749.
Identify if your slides have product codes 1668409 or 8297749 as listed in the recall.
The recall states false low results could miss acute pancreatitis, but false high results do not cause patient harm. The risk is primarily diagnostic confusion.
The recall does not specify a remedy, so contact Ortho-Clinical Diagnostics for guidance on next steps.
Check for product codes 1668409 (60 slides per cartridge) or 8297749 (18 slides per cartridge) and affected lots as listed in the description.
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-0236-2024 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0236-2024 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.
