Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (…

a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.

On May 22, 2025, "URGENT PRODUCT CORRECTION NOTIFICATION" letters were sent to customers. REQUIRED ACTIONS - To prevent this issue from occurring, the shelf expiration date must be entered when manually loading VITROS Diluent Packs on VITROS 4600/5600/XT 7600 Systems. - View the Reagent Management Supply 3 screen to check for any onboard VITROS Diluent Packs marked as expired. o For all VITROS Diluent Packs marked as expired, navigate to View By Reagent View Dil/ANC and confirm the shelf expiration date matches the shelf expiration date on the product labeling. o If the shelf expiration dates do not match, discard the VITROS Diluent Pack and load a new VITROS Diluent Pack. QuidelOrtho will credit your discarded inventory. (Credit will only be issued for within-expiry products.) - Complete and return the enclosed Confirmation of Receipt form no later than May 30, 2025. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory. - Save this notification with your User Documentation or post this notification by each VITROS 4600/5600/XT 7600 System in your laboratory until the issue has been resolved. - Please forward this notification if the affected product was distributed outside of your facility. - 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. Resolution QuidelOrtho has determined root cause, and this issue will be resolved in an upcoming software update. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.

• FDA enforcement recordOfficial FDA database entry for Z-2040-2025
• FDA 510(k) clearance · K031924The device's official FDA premarket clearance record
• FDA device classification · JJEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2160The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ortho-Clinical Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.