VITROS recallZ-0510-2024 · Ortho-Clinical Diagnostics, INc. · initiated Oct 25, 2023

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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)

Recall details

Recall number

Z-0510-2024

Status

Open, Classified

Initiated by the company

Oct 25, 2023

Posted by the FDA

Dec 7, 2023

Recalling firm

Ortho-Clinical Diagnostics, INc.

Quantity

622 units 300 Slides (5 cartridge containing 60 slides)

Product code

KHS

FDA submissions

K182072

Distribution

Nationwide Foreign: Bermuda Canada

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• VITROS 8262396

  Ortho-Clinical Diagnostics, Inc. · ENZYMATIC, CARBON-DIOXIDE
  1 recall0 reports

Product lines

• VITROSOrtho-Clinical Diagnostics, Inc. · 71 models · 806 reports · 96 recalls