Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Chemistry Products Lipase Slides Recalled by Ortho-Clinical Diagnostics, INc. Due to Products 1668409 and 8297749 may contain VITROS Lipase...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics, INc. directly.
Affected Products
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Quantity: 342 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 12 states: CA, CO, FL, GA, IL, IN, KS, NY, NC, TN, TX, VT
About Ortho-Clinical Diagnostics, INc.
Ortho-Clinical Diagnostics, INc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report