directCHECK ACT-LR whole blood quality control, level 2 recallZ-2460-2026 · Accriva Diagnostics, Inc. · initiated Apr 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Accriva Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Assayed Whole blood control contains labeling with incorrect performance range.
FDA root cause category: Process control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-2460-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2026
- Posted by the FDA
- Jun 16, 2026
- Recalling firm
- Accriva Diagnostics, Inc.
- Quantity
- 6060
- Product code
- GGN
- FDA submissions
- K202101
- 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 countries of Canada, Hong Kong, Spain.
Product description
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Code information (models, lots, serial numbers)
Lot #: A6DLA001 Unique Device Identifier: 10711234170373
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- directCHECK ACT-LR Whole Blood Control, Level 2 000DCGLR-2Accriva Diagnostics Holdings, Inc. · Plasma, Coagulation Control1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page