VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ortho-Clinical Diagnostics, INc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Product Codes/Lot Numbers:
Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899
Distribution:
Distributed in: US, CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0236-2024
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