Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is
FDA device recall Z-2673-2011 · posted 2011-06-27 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID.
- Action taken
- Instrumentation Laboratories sent a "FIELD SAFETY NOTIFICATION" letter dated April 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. Included with the letter was an upgrade package containing Software V7.2.2 disk along with installation instructions. Also included with the upgrade kit was a Upgrade Tracking Form to be completed and returned via fax at 781-861-4207 or via e-mail at ra-usa@ilww.com. Customers with questions were directed to contact their local representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 840 units
- Distribution
- Worldwide Distribution-- USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE , INDONESIA, ISRAEL, ITALY,
- Date initiated
- 2011-05-11
- Date posted
- 2011-06-27
- Date terminated
- 2013-03-15
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM PREMIER 3000 (K052121) | Instrumentation Laboratory CO | 2005-10-21 |