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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products ECO2 Slides

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  Class 2 Device Recall VITROS Chemistry Products ECO2 Slides see related information
Date Initiated by Firm October 25, 2023
Date Posted December 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-0510-2024
Recall Event ID 93378
510(K)Number K182072  
Product Classification Enzymatic, carbon-dioxide - Product Code KHS
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
Code Information 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
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, INc.
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact Global Services Organization
800-421-3311
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KHS and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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