Z-0317-2027

Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test...

Name: Z-0317-2027 Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test...
Creator: Accriva Diagnostics, Inc.
Published: 2026-09-14
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2026-09-14 / Open, Classified

FDA source

Recall record

Recall number: Z-0317-2027
Status: Open, Classified
Initiated: 2026-09-14
Posted: 2026-10-30
Recalling firm: Accriva Diagnostics, Inc.
Product: Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may lead retest, or overestimation of patient's anticoagulation, leading to inadequate anticoagulant therapy, which could result in thrombosis.
FDA root cause: Process control
Action: On 9/14/2026, recall notices were mailed to customers who were informed of the following: 1) Please forward this communication to those within your organization who need to be aware of this matter 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 to. 3) Please check your inventory and do not use affected lots. 4) Scrap/destroy all impacted cuvettes and/or boxes. 5) Complete and return the Acknowledgement and Receipt Form via email to [email protected] Questions about receiving credit, should be directed to Customer Service at 1-800-955-9525 or e-mail [email protected]. Technical questions should be directed to Technical Services at 1-800-678-0710 Option 3 or email [email protected].
Quantity in commerce: 28710
Distribution: Worldwide - US Nationwide distribution in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY and the countries of China, Colombia.
Product codes and lots: UDI-DI: 10711234103012, Lot(Expiration): B6JCA005(02/28/2027), C6JCA008(03/31/2027), D6JCA011(04/30/2027), K5JCA041(10/31/2026), C6JCA007(03/31/2027)

Product code JPA

K940401Class IIJr. Microcoagulation SystemInternational Technidyne Corp. / cleared 1994-05-11

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-03. View this recall on fda.gov (opens on fda.gov)