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U.S. Department of Health and Human Services

Class 2 Device Recall Hemochron Activated Clotting Time LowRange (ACTLR) Test Cuvette

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 Class 2 Device Recall Hemochron Activated Clotting Time LowRange (ACTLR) Test Cuvettesee related information
Date Initiated by FirmNovember 05, 2025
Date PostedDecember 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0880-2026
Recall Event ID 97942
510(K)NumberK960749 
Product Classification Activated whole blood clotting time - Product Code JBP
ProductHemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Code Information UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Recalling Firm/
Manufacturer		 Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
For Additional Information ContactPaula Morgan
858-263-2590
Manufacturer 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.
FDA Determined
Cause 2		Packaging process control
ActionOn 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
Quantity in Commerce20250
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JBP
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