Recall Z-0236-2024— Ortho-Clinical Diagnostics, INc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, INc., initiated 2023-09-12. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge). Reason: 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..
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-12
- Firm location
- Rochester, NY, United States
Product description
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.