FDA DevicesClass II
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: D...
Published: June 24, 2026Recall ID: Z-2460-2026Category: devicesCountry: US
Reason for Recall / Hazard
Assayed Whole blood control contains labeling with incorrect performance range.
Product Description & Identification
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Affected Products
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Additional Source Details
| Field | Value |
|---|---|
| City | San Diego |
| State | CA |
| Event id | 98979 |
| Address 1 | 6260 Sequence Dr |
| Code info | Lot #: A6DLA001 Unique Device Identifier: 10711234170373 |
| Postal code | 92121-4358 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 6060 |
| Reason for recall | Assayed Whole blood control contains labeling with incorrect performance range. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Center classification date | 20260616 |
Overview
- Recalling FirmAccriva Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.