Z-1381-05

Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In...

Name: Z-1381-05 Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In...
Creator: International Technidyne Corp.
Published: 2005-04-27
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2005-04-27 / Terminated

FDA source

International Technidyne Corp. began a recall of Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in... on 2005-04-27. The reason FDA records is "Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1381-05
Status: Terminated
Initiated: 2005-04-27
Posted: 2005-08-23
Terminated: 2005-08-25
Recalling firm: Accriva Diagnostics, Inc.
Product: Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.
Product code: JBP Activated Whole Blood Clotting Time
Reason for recall: Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
FDA root cause: Other
Action: Recall letter was sent out on 4/27/2005 via First Class Mail.
Quantity in commerce: 924 boxes x 45 cuvettes per box
Distribution: Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Products were distributed to the VA Medical Center, Los Angeles, CA 90073.
Product codes and lots: Catalog No. JACT-LR Lot No''s: M4JLR164, Exp. 3/2006; M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003, Exp. 4/2006; C5JLR032, Exp. 6/2006.

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)