VITROS ECO2 Chemistry Slides may produce inaccurate CO2 test results
Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving risk-of-harm from diagnostic error (potential misdiagnosis leading to unnecessary or missed treatment of acid-base disorders), with no illnesses or injuries reported. Per the rubric, theoretical risk-of-harm without reported injury receives a High (3) score.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling certain lots of VITROS Chemistry Products ECO2 Slides used in clinical laboratories and healthcare facilities nationwide and internationally. The slides are diagnostic products that measure carbon dioxide (CO2) concentration in blood samples to assess acid-base balance for patient diagnosis and treatment.
The recall affects specific lots from Coating 3598. During routine testing, the manufacturer identified an abnormality in some slides that may cause inaccurate CO2 measurement results. Results may be positively or negatively biased, producing values either higher or lower than actual CO2 levels.
Inaccurate CO2 measurements can result in serious diagnostic errors. Elevated biased results may lead to overdiagnosis of acidosis, causing unnecessary treatment with IV fluids or bicarbonate. Low-biased results may cause healthcare providers to miss alkalosis requiring treatment or fail to detect acidosis entirely, delaying necessary care.
Healthcare facilities should identify products with the affected lot numbers and expiration dates (specified in the recall notice) and contact Ortho-Clinical Diagnostics for instructions on product verification, replacement, or return. No illnesses or injuries have been reported.
The recalled product
- 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 76
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- measurement-error
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI-DI: 10758750004645 Lot Numbers/Exp. Date: 5732-3598-4649 01-Feb-2025
- 5732-3598-4650 01-Feb-2025
- 5732-3598-4651 01-Feb-2025
- 5732-3598-5102 01-Mar-2025
- 5732-3598-5105 01-Mar-2025
- 5732-3598-5189 01-Mar-2025
Distribution
Distributed nationwide across the United States.
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