Lower risk Medical device recall · FDA · Published September 12, 2023

Ortho-Clinical Diagnostics Lipase Slides Recall: Risk of False Pancreatitis Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0236-2024Medical device Ortho-Clinical Diagnostics ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, INc.513 Technology Blvd · Rochester, NY 14626-3601

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/57328-ortho-clinical-diagnostics-lipase-slides-recall-risk-of-false-pancreatitis.

Source Summary by GovInfoNow · govinfonow.com/recall/57328-ortho-clinical-diagnostics-lipase-slides-recall-risk-of-false-pancreatitis · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0236-2024

Cite this page

“Ortho-Clinical Diagnostics Lipase Slides Recall: Risk of False Pancreatitis Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57328-ortho-clinical-diagnostics-lipase-slides-recall-risk-of-false-pancreatitis. Based on FDA recall #Z-0236-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0236-2024%22&limit=1).

The FDA announced on September 12, 2023, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Lipase Slides due to potential test result bias. The agency said the abnormality could cause falsely low or elevated lipase levels, leading to diagnostic confusion.

How to tell if you have it

Brand: Ortho-Clinical Diagnostics
Product: VITROS Chemistry Products Lipase Slides
Product Code 1668409 (contains 60 Slides per Cartridge), UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557
Product Code 8297749 (contains 18 slides per cartridge), UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899

The hazard

According to the FDA, products may contain slides with an abnormality causing -46% to +86% bias in lipase results. 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.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Other recent recalls include Ortho-Clinical LAC Slides Recall (2025-07-29), Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12). Other recent recalls of similar products include Siemens Atellica CH A1c_E Test Recall (2026-06-08), LH One Step Ovulation Test Device Recall (2025-11-22), and Siemens Atellica CH Urine Albumin Recall (2026-01-20).

How to tell if you have this one

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.

Brand
Ortho-Clinical Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Identify if your slides have product codes 1668409 or 8297749 as listed in the recall.

Where it went and when

Where it was distributed

Distributed in 12 states, and outside the U.S.

FDA distribution: “US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, New York, North Carolina, Tennessee, Texas, Vermont.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 12, 2023Firm started the recall
Nov 6, 2023FDA classified it Class II
Nov 15, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57328-ortho-clinical-diagnostics-lipase-slides-recall-risk-of-false-pancreatitis">Ortho-Clinical Diagnostics Lipase Slides Recall: Risk of False Pancreatitis Results (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0236-2024 (September 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0236-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.