Z-2460-2026 Class II Ongoing
FDA device recall Z-2460-2026 was initiated by Accriva Diagnostics, Inc. on April 30, 2026 and is designated Class II. Reason for recall: Assayed Whole blood control contains labeling with incorrect performance range. The recall status is ongoing. Affected quantity: 6060.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- April 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6060
Product Description
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Reason for Recall
Assayed Whole blood control contains labeling with incorrect performance range.
Distribution Pattern
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.
Code Information
Lot #: A6DLA001 Unique Device Identifier: 10711234170373