VITROS Chemistry Products ECO2 Slides-For in vitro recall
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon…
Why was VITROS Chemistry Products ECO2 Slides-For in vitro 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon…
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- Quantity
- 622 units 300 Slides (5 cartridge containing 60 slides)
- Distribution
- Nationwide Foreign: Bermuda Canada
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)