VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per car...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0236-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0236-2024.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0236-2024.
Ortho-Clinical Diagnostics, INc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Ortho-clinical Diagnostics, Inc. Recall FAQ
Ortho-clinical Diagnostics, Inc. is the subject of a medical devices safety report: VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per car.... The notice was published on September 12, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 342 units are potentially affected.