FDA Enforcement
Class II
Ongoing
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Recall: Z-2460-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2460-2026
- Event ID
- 98979
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Accriva Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- June 24, 2026
- Initiation Date
- April 30, 2026
- Classification Date
- June 16, 2026
- Address
- 6260 Sequence Dr, San Diego, CA, 92121-4358, United States
Description
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.
Code Info
Lot #: A6DLA001 Unique Device Identifier: 10711234170373
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.
Quantity
6060