Reported Dec 13, 2023 · Ongoing
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, INc. · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- 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 Code8262396
- Lot codes and dates
- UDI-DI10758750004645 Lot Numbers/Exp
- Date
5732-3598-4649 01-Feb-20255732-3598-4650 01-Feb-20255732-3598-4651 01-Feb-20255732-3598-5102 01-Mar-20255732-3598-5105 01-Mar-20255732-3598-5189 01-Mar-2025
- Amount recalled
- 622 units 300 Slides (5 cartridge containing 60 slides)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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