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.
FDA Recall Z-2462-2010 · Posted 2010-09-23
Advertisement
Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2010-08-20
Date Terminated2012-07-25
Product Quantity277
Reason for Recall
Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
Firm 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4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice..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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution - USA, including the state of Indiana
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement