directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
FDA device recall Z-2460-2026 · posted 2026-06-16 · Open, Classified
Recall details
- Recalling firm
- Accriva Diagnostics, Inc.
- Reason for recall
- Assayed Whole blood control contains labeling with incorrect performance range.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GGN
- Quantity affected
- 6060
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the cou
- Date initiated
- 2026-04-30
- Date posted
- 2026-06-16
- Location
- San Diego, CA
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