GCX Mountable Downloader-Recharger recallZ-2462-2010 · Abbott Point of Care Inc. · initiated Aug 20, 2010
Terminated All recalls posted in September 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
FDA root cause category: Device Design
What the company is doing
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the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice..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.
Recall details
- Recall number
- Z-2462-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 20, 2010
- Posted by the FDA
- Sep 23, 2010
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 277
- Product code
- CGA
- FDA submissions
- K001387
- Distribution
- Nationwide Distribution - USA, including the state of Indiana
Product description
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.
Code information (models, lots, serial numbers)
List number: 06F23-57/514005, part number 016060-01.
Other devices under the same FDA submission
7 devices cleared under K001387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 04P75-31Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE5 reports
- i-STAT 04P75-32Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE4 reports
- i-STAT 04P75-30Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE3 reports
- i-STAT 04P75-35Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
- i-STAT 04P75-36Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
- i-STAT 04P75-38Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
- i-STAT 04P75-44Abbott Point Of Care Inc. · GLUCOSE OXIDASE, GLUCOSE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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