Device Recall Instrumentation Laboratory GEM Premier

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.

Serial Numbers range: 06050100 -11024479

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of CANADA ISRAEL ITALY APAN KUWAIT MALAYSIA MEXICO NETHERLANDS NORWAY PANAMA POLAND PORTUGAL PUERTO RICO SAUDI ARABIA SLOVENIA SPAIN SWEDEN SWITZERLAND TAIWAN TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and URUGUAY.

Instrumentation Laboratory GEM Premier 4000 || PN 00025000000 || The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus