Recall Z-2673-2011
Instrumentation Laboratory Co. · initiated May 11, 2011
Product
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 hematocrit. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Codes / lots: Serial Numbers range: 09020100 through 11041157.
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.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-2673-2011
- Initiated
- May 11, 2011
- Posted by FDA
- June 27, 2011
- Terminated
- March 15, 2013
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- 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, SWEDEN, SWITZERLAND, THAILAND ,TURKEY, and UNITED KINGDOM.
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA