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

FDA device recall Z-2462-2010 · posted 2010-09-23 · Terminated

Recall details

Recalling firm

Abbott Point of Care Inc.

Reason for recall

Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.

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the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice..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.

Root cause

Device Design

Status

Terminated

Product code

CGA

Quantity affected

277

Distribution

Nationwide Distribution - USA, including the state of Indiana

Date initiated

2010-08-20

Date posted

2010-09-23

Date terminated

2012-07-25

Location

Princeton, NJ

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