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U.S. Department of Health and Human Services

Class 3 Device Recall Hemochron

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 Class 3 Device Recall Hemochronsee related information
Date Initiated by FirmApril 27, 2005
Date PostedAugust 23, 2005
Recall Status1 Terminated 3 on August 25, 2005
Recall NumberZ-1381-05
Recall Event ID 31937
510(K)NumberK960749 
Product Classification Activated Whole Blood Clotting Time - Product Code JBP
ProductHemochron 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 ContactDave 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
ActionRecall letter was sent out on 4/27/2005 via First Class Mail.
Quantity in Commerce924 boxes x 45 cuvettes per box
DistributionProducts 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 CycleTPLC 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) Database510(K)s with Product Code = JBP
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