Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Who

FDA device recall Z-0880-2026 · posted 2025-12-03 · Open, Classified

Recall details

Recalling firm

Accriva Diagnostics, Inc.

Reason for recall

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

Action taken

On 11/5/2025, recall notices were mailed to Medical Directors, Lab Directors, Clinical Laboratory Managers, or Point of Care Coordinators who were asked to do the following: 1) Forward this communication to those within your organization who need to be aware and verify they understand the procedure and can complete the enclosed forms. 2) Forward the enclosed customer notification to all other organizations where affected devices may have been transferred. 3) Please check your inventory for affected devices. If you find any, please refrain from opening any pouches or using the product. Destroy all impacted cuvette pouches and/or boxes of the affected devices. 4) Complete and return the Customer Acknowledgment Form via email to ilsd_ra.na@werfen.com 5) If you have questions regarding replacement product, please contact the firm's Customer Service at 1-800-955-9525 or e-mail to customerservice.na@werfen.com. 6) For any technical related questions, please contact the firm's Technical Services at 1-800-678-0710 Option No. 1 or email to: techsupport.na@werfen.com

Root cause

Packaging process control

Status

Open, Classified

Product code

JBP

Quantity affected

20250

Distribution

Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA.

Date initiated

2025-11-05

Date posted

2025-12-03

Location

San Diego, CA

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