Recall Z-2460-2026 ยท GGN Plasma, Coagulation Control
Accriva Diagnostics, Inc.
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
| Date | Jun 16, 2026 (initiated Apr 30, 2026) |
| Status | Open, Classified |
| Reason | Assayed Whole blood control contains labeling with incorrect performance range. |
| Root cause | Process control |
| Action | On May 8, 2026 Accriva Diagnostics, issued a Urgent Medical Device Recall Notification to affected consignees via E-Mail.. Accriva asked consignees to take the following actions: 1. Please forward this communication to those within your organization who need to become aware 2. Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3. Forward the enclosed customer notification to those in your organization that are responsible for performing quality control testing and/or supervise testing. 4. Please check your inventory to d |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activa Accriva Diagnostics, Inc., Dec 29, 2021 |