Lower risk Medical device recall · FDA · Published October 25, 2023

Ortho-Clinical VITROS ECO2 Slides Recall: Risk of Incorrect CO2 Test Results

Ortho-Clinical recalls VITROS ECO2 Slides with potential for inaccurate CO2 test results. Affected lots may cause overdiagnosis of acidosis or alkalosis, leading to unnecessary treatments. Check product codes and lot numbers for affected items.

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

🇺🇸 FDA recall #Z-0510-2024Medical device Ortho-Clinical ›

Lower-risk 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.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS ECO2 Slides that may produce incorrect carbon dioxide (CO2) test results. This could lead to unnecessary treatments for acidosis or alkalosis, which are serious medical conditions. The recall affects specific lots of slides used in laboratory testing. Read more at govinfonow.com/recall/57010-ortho-clinical-vitros-eco2-slides-recall-risk-of-incorrect-co2.

Source Summary by GovInfoNow · govinfonow.com/recall/57010-ortho-clinical-vitros-eco2-slides-recall-risk-of-incorrect-co2 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0510-2024

Cite this page

“Ortho-Clinical VITROS ECO2 Slides Recall: Risk of Incorrect CO2 Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57010-ortho-clinical-vitros-eco2-slides-recall-risk-of-incorrect-co2. Based on FDA recall #Z-0510-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0510-2024%22&limit=1).

The FDA announced on 2023-10-25 that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ECO2 Slides due to potential abnormality causing biased total carbon dioxide results. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Chemistry Products ECO2 Slides
Product Code: 8262396
Lot Numbers: 5732-3598-4649, 5732-3598-4650, 5732-3598-4651, 5732-3598-5102, 5732-3598-5105, 5732-3598-5189
Expiry Dates: 01-Feb-2025, 01-Mar-2025
Distribution: Nationwide, Bermuda, Canada

The hazard

The FDA said that some lots from Coating 3598 may contain consecutive slides that do not function as intended. These abnormalities can cause biased total carbon dioxide results, potentially leading to overdiagnosis of acidosis or alkalosis and unnecessary therapies.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics has had 53 other recalls since 2017-07-10. Recent brand recalls include VITROS LAC Slides (2025-07-29), VITROS Ca Slides (2025-07-09), and VITROS OP Reagent Gen 15 (2025-06-12). Other recent recalls of similar products include Siemens Epoc Blood Test Cards (2026-04-02), Becton Dickinson BD GasP (2026-04-07), and Vivoo pH Test (2025-11-22).

How to tell if you have this one

Check for product code 8262396 and lot numbers 5732-3598-4649, 5732-3598-4650, 5732-3598-4651, 5732-3598-5102, 5732-3598-5105, or 5732-3598-5189 with expiration dates of February 1, 2025, or March 1, 2025.

Brand
Ortho-Clinical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product code (8262396) and lot numbers listed above to confirm if your slides are affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Bermuda Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

Oct 25, 2023Firm started the recall
Dec 7, 2023FDA classified it Class II
Dec 13, 2023Published in FDA’s Enforcement Report

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

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Keep exploring

More Ortho-Clinical recalls

Link to this recall

<a href="https://govinfonow.com/recall/57010-ortho-clinical-vitros-eco2-slides-recall-risk-of-incorrect-co2">Ortho-Clinical VITROS ECO2 Slides Recall: Risk of Incorrect CO2 Test 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-0510-2024 (October 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0510-2024 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.