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.
This recall has been terminated (originally issued September 23, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- August 20, 2010
- Posted
- September 23, 2010
- Terminated
- July 25, 2012
- Recall Number
- Z-2462-2010
- Quantity
- 277
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
Distribution
Nationwide Distribution - USA, including the state of Indiana
Lot / Code Info
List number: 06F23-57/514005, part number 016060-01.
Root Cause
Device Design
Action Taken
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the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice..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.