FDA Medical devices recall ·
directCHECK ACT-LR whole blood quality control, level 2 Model recall
- Recall number
- Z-2460-2026
- Date
- (initiated April 30, 2026)
- Company / brand
- Accriva Diagnostics, Inc.
6260 Sequence Dr, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6060
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Why was it recalled?
Assayed Whole blood control contains labeling with incorrect performance range.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2460-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.