directCHECK ACT-LR whole blood quality control recall (Accriva Diagnostics, Inc.)
Medical deviceClass IIOngoing
Summary: Accriva Diagnostics, Inc. is recalling directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2. Reason: Assayed Whole blood control contains labeling with incorrect performance range.
What is being recalled
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Why
Assayed Whole blood control contains labeling with incorrect performance range.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: 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)
How to tell if yours is affected
Lot #: A6DLA001 Unique Device Identifier: 10711234170373
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2460-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 30, 2026 |
| Reported | June 24, 2026 |
| Company | Accriva Diagnostics, Inc. |
| Company location | San Diego, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6060 |
More recalls from Accriva Diagnostics, Inc. · all medical device recalls · recalls from April 2026