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U.S. Department of Health and Human Services

Class 3 Device Recall GCX Mountable DownloaderRecharger;

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  Class 3 Device Recall GCX Mountable DownloaderRecharger; see related information
Date Initiated by Firm August 20, 2010
Date Posted September 23, 2010
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-2462-2010
Recall Event ID 56560
510(K)Number K001387  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product GCX Mountable Downloader-Recharger;
(accessory to the i-STAT Portable Clinical Analyzer (model 300).
The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.
Code Information List number: 06F23-57/514005, part number 016060-01.
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter J. Scott
609-454-9270
Manufacturer Reason
for Recall		 Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
FDA Determined
Cause 2		 Device Design
Action Abbott Point of Care, Inc. sent Urgent Recall Notices, dated August 20, 2010, by Federal Express to two Clarion Health locations. The letter identified the product, the issue, and the actions to be taken by the firm and the customers. 1) An Abbott Point of Care representative will contact the customers to plan the replacement of affected product at their facility. 2) Replacement will occur in batches of approximately 50 units at a time. 3) Abbott will provide personnel to perform the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice.. If you have any questions regarding this information please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.
Quantity in Commerce 277
Distribution Nationwide Distribution - USA, including the state of Indiana
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 = CGA and Original Applicant = I-STAT CORP.
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