Z-1732-2009

Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the...

Name: Z-1732-2009 Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the...
Creator: International Technidyne Corp.
Published: 2009-05-05
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2009-05-05 / Terminated / root cause: manufacturing process

FDA source

International Technidyne Corp. began a recall of Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems... on 2009-05-05. The reason FDA records is "One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1732-2009
Status: Terminated
Initiated: 2009-05-05
Posted: 2009-08-21
Terminated: 2009-09-30
Recalling firm: Accriva Diagnostics, Inc.
Product: Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne Corp., Edison, NJ 08820. The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
Product code: JBP Activated Whole Blood Clotting Time
Reason for recall: One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An "Urgent - Medical Device Recall" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be completed in all cases. If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at [email protected].
Quantity in commerce: 173 boxes of 45 cuvettes
Distribution: Nationwide.
Product codes and lots: Lot number K8JLR118.

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)