Accriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control

Assayed Whole blood control contains labeling with incorrect performance range.

On May 8, 2026 Accriva Diagnostics, issued a Urgent Medical Device Recall Notification to affected consignees via E-Mail.. Accriva asked consignees to take the following actions: 1. Please forward this communication to those within your organization who need to become aware 2. Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3. Forward the enclosed customer notification to those in your organization that are responsible for performing quality control testing and/or supervise testing. 4. Please check your inventory to determine if you have any boxes of directCHECK Whole BloodControls. If you have this product in stock, do NOT use. 5. Please destroy all impacted boxes and document on the enclosed form. 6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc. 7. If you have any technical questions, please contact Technical Services at 1-800-678-0710 Option 3 or e-mail techsupport.na@werfen.com.

• FDA enforcement recordOfficial FDA database entry for Z-2460-2026
• FDA 510(k) clearance · K202101The device's official FDA premarket clearance record
• FDA device classification · GGNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5425The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Accriva 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.