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

FDA device recall Z-2088-2014 · posted 2014-07-21 · Terminated

Recall details

Recalling firm

ITC-Nexus Dx

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.

Action taken

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: Techsupport@itcmed.com 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.

Root cause

Device Design

Status

Terminated

Product code

JPA

Quantity affected

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.

Date initiated

2014-06-20

Date posted

2014-07-21

Date terminated

2014-12-11

Location

Edison, NJ

Related 510(k) clearances