Date Initiated by Firm |
April 27, 2005 |
Date Posted |
August 23, 2005 |
Recall Status1 |
Terminated 3 on August 25, 2005 |
Recall Number |
Z-1381-05 |
Recall Event ID |
31937 |
510(K)Number |
K960749
|
Product Classification |
Activated Whole Blood Clotting Time - Product Code JBP
|
Product |
Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820. |
Code Information |
Catalog No. JACT-LR Lot No''s: M4JLR164, Exp. 3/2006; M4JLR165, Exp. 3/2006; A5JLR001, Exp. 4/2006; A5JLR002, Exp. 4/2006; A5JLR003, Exp. 4/2006; C5JLR032, Exp. 6/2006. |
Recalling Firm/ Manufacturer |
International Technidyne Corp. 6 Olsen Ave Edison NJ 08820-2419
|
For Additional Information Contact |
Dave Gronostajski 732-548-5700 Ext. 265
|
Manufacturer Reason for Recall |
Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letter was sent out on 4/27/2005 via First Class Mail. |
Quantity in Commerce |
924 boxes x 45 cuvettes per box |
Distribution |
Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Products were distributed to the VA Medical Center, Los Angeles, CA 90073. |
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.
|
510(K) Database |
510(K)s with Product Code = JBP and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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