# FDA recall Z-0236-2024

> **Ortho-Clinical Diagnostics, INc.** · Class II · device recall initiated 2023-09-12.

## Product

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.

## Distribution

US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea

## Key facts

- **Recall number:** Z-0236-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, INc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-12
- **Report date:** 2023-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0236-2024

## Citation

> AI Analytics. FDA recall Z-0236-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0236-2024. Source: US FDA. Licensed CC0.

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