directCHECK ACT-LR whole blood quality control recall: Labeling Error
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Why was directCHECK ACT-LR whole blood quality control recalled?
Assayed Whole blood control contains labeling with incorrect performance range.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: A6DLA001 Unique Device Identifier: 10711234170373
- Product
- directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
- Recalling firm
- Accriva Diagnostics, Inc.
- Quantity
- 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 countries of Canada, Hong Kong, Spain.
- Recall date
- June 24, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)