Recall Z-0510-2024 ยท KHS Enzymatic, Carbon-Dioxide
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 potenti
| Date | Dec 7, 2023 (initiated Oct 25, 2023) |
| Status | Open, Classified |
| 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 al |
| 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 la |
| Quantity | 622 units 300 Slides (5 cartridge containing 60 slides) |
| Distribution | Nationwide Foreign: Bermuda Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides Ortho-Clinical Diagnostics, Inc., Oct 30, 2018 |