Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CHE Slides (Japan)

Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

On June 10, 2025, "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letters were sent to distributors and customers. CUSTOMER LETTERS: REQUIRED ACTIONS " Monitor VITROS CHE Slides QC results to detect a drift in VITROS Performance Verifiers I and II below 2x Within-lab SD limits. If QC results are below 2x WLSD, perform QC again using freshly reconstituted vials of VITROS Performance Verifiers I and II. " Complete the enclosed Confirmation of Receipt form no later than June 18, 2025. " Save this notification with your User Documentation or post this notification near your laboratory's fluid reconstitution location until the issue has been resolved. " Please forward this notification if the affected products were distributed outside of your facility. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization. QuidelOrtho's investigation is ongoing, and we are working to identify root cause. We will communicate again after root cause has been determined and the issue has been resolved. Please note that until this issue is resolved, future lots of VITROS Performance Verifiers I and II may not meet the 7-day reconstituted stability for CHE. DISTRIBUTORS: REQUIRED ACTIONS " Please send the enclosed customer letter and customer Confirmation of Receipt form to all customers who have been shipped VITROS Chemistry Products Performance Verifiers AND VITROS CHE Slides from August 1, 2023, to date. " Complete the enclosed distributor Confirmation of Receipt form no later than June 18, 2025. " Please forward this notification if the affected products were distributed outside of your facility. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.

• FDA enforcement recordOfficial FDA database entry for Z-2123-2025
• FDA device classification · DIHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.3240The 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.