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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JPA
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