Recall Z-2673-2011 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Instrumentation Laboratory Co.
Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood for pH, pC02, p02, Na+, K+, Ca++, glucose, lactate and hema
| Date | Jun 27, 2011 (initiated May 11, 2011) |
| Status | Terminated |
| Reason | Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, JAPAN , KOREA, REPUBLIC OF CHINA, MALAYSIA, NETHERLANDS , PHILIPPINES, POLAND, PORTUGAL, SPAIN, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052121 | GEM PREMIER 3000 Instrumentation Laboratory CO, Oct 21, 2005 |