Z-0880-2026Class II

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

Name: Z-0880-2026 Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron...
Creator: Accriva Diagnostics, Inc.
Published: 2025-11-05
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2025-11-05 / Open, Classified / root cause: packaging

FDA source

Accriva Diagnostics, Inc. began a recall of Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System on 2025-11-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0880-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-05
Posted: 2025-12-03
Recalling firm: Accriva Diagnostics, Inc.
Product: Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Product code: JBP Activated Whole Blood Clotting Time
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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 [email protected] 5) If you have questions regarding replacement product, please contact the firm's Customer Service at 1-800-955-9525 or e-mail to [email protected]. 6) For any technical related questions, please contact the firm's Technical Services at 1-800-678-0710 Option No. 1 or email to: [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0880-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0880-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-03

Product code JBP

K960749Class IIHemochron Jr. Microcoagulation Low Range ActInternational Technidyne Corp. / cleared 1996-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)