Recall Z-2462-2010 ยท CGA Glucose Oxidase, Glucose
Abbott Point of Care Inc.
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.
| Date | Sep 23, 2010 (initiated Aug 20, 2010) |
| Status | Terminated |
| Reason | Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer. |
| Root cause | 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 |
| Quantity | 277 |
| Distribution | Nationwide Distribution - USA, including the state of Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-Stat Corp., Oct 5, 2000 |