FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics, INc.: 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 Code: 8262396
- Recall number
- Z-0510-2024
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- 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 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 Code: 8262396
- Status
- Open, Classified
- Initiated
- 2023-10-25
- Posted
- 2023-12-07
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Ortho Clinical Diagnostics (QuidelOrtho) issued Urgent Product Correction Notification letter to Distributors and End-Users on 10.25.23. Letter states reason for recall, health risk and action to take: Discontinue using, render unusable, and discard any remaining inventory of the affected lots of VITROS ECO2 Slides from your laboratory. " If available, use an alternate, unaffected lot of VITROS ECO2 Slides for testing. " Complete and return the enclosed Confirmation of Receipt form no later than November 2, 2023. QuidelOrtho will send a replacement lot or credit your account. " Ensure your laboratory follows the calibration instructions provided in the VITROS ECO2 Slides Instructions For Use. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System until your laboratory receives a lot of VITROS ECO2 Slides unaffected by this issue. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization (formerly Ortho Care.) We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. Enclosure: Confirmation of Receipt Form (Ref. CL2023-248_CofR)
- Quantity
- 622 units 300 Slides (5 cartridge containing 60 slides)
- Distribution
- Nationwide Foreign: Bermuda Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- K182072
- PMA numbers
- not on file
- Product code
- KHS
- Firm FEI
- 1000305840
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28