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.
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.
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.
The affected slides may have an abnormality that causes CO2 test results to be too high or too low. This could lead to overdiagnosis of acidosis (too acidic blood) or missing alkalosis (too alkaline blood), resulting in unnecessary IV fluids, bicarbonate, or electrolyte treatments.
Healthcare facilities using the VITROS ECO2 Slides for in vitro diagnostic testing are most at risk. Patients receiving inaccurate CO2 test results could be affected if the slides are used in critical medical decisions.
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.
Verify the product code (8262396) and lot numbers listed above to confirm if your slides are affected.
Ortho-Clinical confirmed during routine testing that some lots of VITROS ECO2 slides from Coating 3598 may not function correctly, leading to inaccurate CO2 test results.
The affected slides may cause overdiagnosis of acidosis or alkalosis, which could lead to unnecessary IV fluids, bicarbonate, or electrolyte treatments.
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.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0510-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0510-2024 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
