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U.S. Department of Health and Human Services

Class 2 Device Recall GEM Check Coag Whole Blood Controls

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  Class 2 Device Recall GEM Check Coag Whole Blood Controls see related information
Date Initiated by Firm July 08, 2010
Date Posted July 28, 2010
Recall Status1 Terminated 3 on September 23, 2010
Recall Number Z-2107-2010
Recall Event ID 56169
510(K)Number K944691  
Product Classification Coagulation Control Plasma - Product Code GGN
Product GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert:
IVD. 15/pk. 06260061600.
Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125.

Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
Code Information Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.
Recalling Firm/
Manufacturer		 International Technidyne Corporation
20 Corporate Pl S
Piscataway NJ 08854-6144
For Additional Information Contact Larry Picciano
732-548-5700 Ext. 4451
Manufacturer Reason
for Recall		 Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
FDA Determined
Cause 2		 Error in labeling
Action Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.
Quantity in Commerce 95 kits C9GC5001; 32 kits G9GC5003; 46 kits J9GC5004; 5 kits C0GC5001; Each kit contains 15 vials.
Distribution Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
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 = GGN and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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