Z-2462-2010

GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX...

Name: Z-2462-2010 GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX...
Creator: Abbott Point of Care Inc.
Published: 2010-08-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-08-20 / Terminated / root cause: design

FDA source

Abbott Point of Care Inc. began a recall of GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a... on 2010-08-20. The reason FDA records is "Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2462-2010
Status: Terminated
Initiated: 2010-08-20
Posted: 2010-09-23
Terminated: 2012-07-25
Recalling firm: Abbott Medical
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.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
Root cause tag: design
FDA 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the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice..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
Product codes and lots: List number: 06F23-57/514005, part number 016060-01.

Product code CGA

K001387Class III-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. / cleared 2000-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)