FDA recall, , Moderate risk
DirectCHECK ACT-LR Whole Blood Quality Control, Level 2
The whole blood quality control has labeling with an incorrect performance range.
Summary by Recall Canary from the FDA notice
What happened
Accriva Diagnostics, Inc., of San Diego, California, began a recall on April 30, 2026, of directCHECK ACT-LR whole blood quality control, level 2, because the assayed whole blood control contains labeling with an incorrect performance range. The recall was added to the FDA's Enforcement Report and classified on June 16, 2026, and was in the FDA's weekly enforcement report on June 24, 2026.
The product was distributed worldwide, including nationwide in the United States and in Canada, Hong Kong, and Spain.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
directCHECK ACT-LR whole blood quality control, level 2
- Model number
- DCGLR-2
- UDI-DI
- 10711234170373
- Lot code
- A6DLA001
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and the countries of Canada, Hong Kong, Spain.
- Company
- Accriva Diagnostics, Inc.San Diego, California
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98979
- Recall number
- Z-2460-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
