Z-2088-2014Class II

Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test...

Name: Z-2088-2014 Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test...
Creator: ITC-Nexus Dx
Published: 2014-06-20
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2014-06-20 / Terminated / root cause: design

FDA source

ITC-Nexus Dx began a recall of Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103 on 2014-06-20. FDA classified it as Class II and gives the reason as "Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2088-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Posted: 2014-07-21
Terminated: 2014-12-11
Recalling firm: Accriva Diagnostics, Inc.
Product: Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Root cause tag: design
FDA root cause: Device Design
Action: ITC issued an Urgent Medical Device Recall Letters/Response Forms dated June 20, 2014, to End-users and US Distributors were notified. ITC asks that this communication be forwarded to all those within your organization who need to be aware of this matter. If any affected products have been forwarded to another facility, a copy of this communication should be forwarded to them immediately. Customers should check their inventory for the affected lot. The affected lot should not be used and quarantined until return to ITC. The attached form should be completed and returned to ITC within 10 days. ITC will review the form and contact the customer to coordinate any returns. For questions, please contact Technical Support: Telephone 732-548-5700, Extension 4011 E-mail: [email protected] Normal business hours are Monday through Friday, 8:00 AM to 6:30 PM, Eastern Time.For urgent matters, Technical Support is available 24 hours per day, 7 days a week.
Quantity in commerce: US- 315 cuvettes; OUS - 2835 cuvettes
Distribution: Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Product codes and lots: Lot Number A4JCA001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2088-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2088-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-21

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