VITROS Chemistry Products Lipase Slides — Class II medical device recall Z-0236-2024
Ongoing recall by Ortho-Clinical Diagnostics, INc., reported 2023-11-15, distributed in CA, CO, FL, GA, IL, IN, KS, NC…. Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +8
| Recall number | Z-0236-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, INc., Rochester, NY, United States |
| Recall initiated | 2023-09-12 |
| Classified | 2023-11-06 |
| Reported by FDA | 2023-11-15 |
| Distributed | CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT |
| Countries outside the US | CA, FR, IN, JP, KR |
| Quantity | 342 units |
| UPC / GTIN / UDI-DI | 10758750004683, 10758750009510 |
| Lot numbers | 5905-3348-1557, 5905-3348-2899 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0236-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.