Recall Z-2460-2026— Accriva Diagnostics, Inc.

Name: FDA recall Z-2460-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Class II · Ongoing

Class II FDA medical device recall by Accriva Diagnostics, Inc., initiated 2026-04-30. It names one FDA 510(k) clearance: K202101. Product: 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..

Recalling firm: Accriva Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-30
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2Accriva Diagnostics, Inc.·cleared 2021-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.