VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only — Class II medical device recall Z-0510-2024
Ongoing recall by Ortho-Clinical Diagnostics, INc., reported 2023-12-13, distributed nationwide. Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of
| Recall number | Z-0510-2024 |
|---|---|
| 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 | 2023-10-25 |
| Classified | 2023-12-07 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA |
| UPC / GTIN / UDI-DI | 10758750004645 |
| Lot numbers | 5732-3598-4649, 5732-3598-4650, 5732-3598-4651, 5732-3598-5102, 5732-3598-5105, 5732-3598-5189 |
Product
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Product Code: 8262396
Reason for recall
Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased total carbon dioxide (CO2) results leading to either overdiagnosis of acidosis or missing alkalosis, both which may prompt unnecessary therapies such as IV fluids and/or bicarbonate or overdiagnosis of alkalosis which may also result in unnecessary use of IV fluids and electrolyte replacement or failure to detect acidosis and necessary treatment.
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-0510-2024. 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.