Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Hemocrhon Jr APTT Cuvettes

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Hemocrhon Jr APTT Cuvettes see related information
Date Initiated by Firm June 20, 2014
Date Posted July 21, 2014
Recall Status1 Terminated 3 on December 11, 2014
Recall Number Z-2088-2014
Recall Event ID 68659
510(K)Number K940401  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Code Information Lot Number A4JCA001
Recalling Firm/
Manufacturer		 ITC-Nexus Dx
23 Nevsky St
Edison NJ 08820-2425
Manufacturer 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.
FDA Determined
Cause 2		 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: 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
-
-