Z-0510-2024Class II

VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides...

Name: Z-0510-2024 VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides...
Creator: Ortho-Clinical Diagnostics, INc.
Published: 2023-10-25
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-10-25 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, INc. began a recall of VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2)... on 2023-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0510-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-25
Posted: 2023-12-07
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
Product code: KHS Enzymatic, Carbon-Dioxide
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 622 units 300 Slides (5 cartridge containing 60 slides)
Distribution: Nationwide Foreign: Bermuda Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0510-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0510-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-07

Product code KHS

K182072Class IIVITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc. / cleared 2018-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)