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Open, Classified

directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

FDA Recall Z-2460-2026 · Posted 2026-06-16

Recalling FirmAccriva Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeGGN
Date Initiated2026-04-30
Product Quantity6060

Reason for Recall

Assayed Whole blood control contains labeling with incorrect performance range.

Firm 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 determine if you have any boxes of directCHECK Whole BloodControls. If you have this product in stock, do NOT use. 5. Please destroy all impacted boxes and document on the enclosed form. 6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc. 7. If you have any technical questions, please contact Technical Services at 1-800-678-0710 Option 3 or e-mail [email protected].

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202101GEM 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. · 2021-12-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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