Device Recall Instrumentation Laboratory

Lot Number: 306355 Expires: 8/31/2003

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, FL, NY, PA, TN,

GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. || Part No. 24330004 (300 Sample Size) || For In-Vitro Diagnostic Use

Lot Number: 306360 Expires: 8/31/2003

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, FL, NY, PA, TN,

GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. || Part No. 24345004 (450 Sample Size) || For In-Vitro Diagnostic Use

Software version prior to V2.1

Hematology and Pathology Devices

2

No

Florida Canada

ACL Advance Instrument Analyzer

Serial numbers starting with 18412

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Foreign: Canada

GEM PREMIER 3000

Serial Numbers range: 09020100 through 11041157.

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

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.