Clinical Chemistry and Clinical Toxicology Devices

Determine the different analytes in samples from the human body

PRIME CCS COMPLETE, specific serials.

The STAT PROFILE PRIME CCS analyzer system analyzer: is intended for in vitro diagnostic use by health professionals in clinical laboratory environments and intensive care units for the quantitative determination of PH, PCO2, PO2, HCT, NA +, K +, CL- , ICA, GLU (GLUCOSE) AND LAC (LACTATE) in heparinized whole blood, serum, plasma and urine. . In samples of critical care patients or that require these measurements for their treatment or control of the disease.

Universal blood gas analyzer

Model: StatStrip and StatSensor, Affected: All batteries without expiry dates

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Lots 806050, 806182, 806242, 806567, 806721, 806752, and 807246.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.

Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer || Catalog # 35238 || Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

Version 4.08

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI

CCX Operating Software , Version 4.08

All S/N''s

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI

Stat Profile Critical Care PLUS (CCX) Analyzer || Catalog Number: 37413

All S/N''s

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI

Stat Profile Critical Care (CCX) Analyzer || Catalog Number: 35942

Devices shipped between March 30-31, 2004

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany

ABG Replacement Pump Assembly || Catalog Number: 37092

Domestic S/N: Y02902141 Y0290211Z Y02103141 Y02303101 Y02503281  International S/N: Y02603111 Y02603091

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany

Stat Profile Critical Care Xpress CCX+ (R) Anaylzer || Catalog NUmber: 37555 || R= Refurbished

Serial Numbers: Inst. S/N Y01902211 Y01203021 Y01B02101

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany

Stat Profile Critical Care Xpress CCX (R) Analyzer || Catalog Number: 37562 || R= Refurbished

Domestic Serial Numbers: Y02C03170 Y02C03140 Y02C03180 Y02104060 Y02104180 Y02104070 Y02104210 Y02104080 Y02204180  International S/N: Y02204030 Y02204040 Y02204050 Y02204110 Y02204120 Y02204140 Y02204190 Y02304020 Y02C03190 Y02C03160 Y02C03090 Y02204060 Y02C03070 Y02304050 Y02C03050 Y02104090 Y02104230 Y02104170 Y02104020 Y02304070

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany

Stat Profile Critical Care Xpress CCX+ Analyzer || Catalog Number: 37413

Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040 Y01104100 Y01104110 Y01304150 Y01304120 Y01104150 Y01104130 Y01104050 Y01104190 Y01104160 Y01104220 Y01204020 Y01204100 Y01204010 Y01204130 Y01204150 Y01204160 Y01703120 Y01304040 Y01304010 Y01304110  International S/N: Inst. S/N Y01204200 Y01304030 Y01304130 Y01304140 Y01304090 Y01304100 Y01104140 Y01204070 Y01204170 Y01104120 Y01C03150

Clinical Chemistry and Clinical Toxicology Devices

2

No

CA, IL, LA, MA ,NJ, NY, OH, PA, TX International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany

Stat Profile Critical Care Xpress (CCX) Analyzer || Catalog Number: 35942

All current software versions

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US (Nationwide) Foreign: Albania Algeria Argentina Australia Austria Bangladesh Benin Bolivia Brazil Canada Chile China Colombia Costa Rica Czech Republic ECUADOR Egypt El Salvador Finland France Germany Ghana Greece Guatemala Guyana Honduras Hong Kong Hungary ICELAND India Iran Israel Italy Ivory Coast Japan Jordan Kenya Korea Latvia Macedonia Malaysia Mexico Nepal Netherlands Nigeria Pakistan Pakistan Palestine Peru Philippines Poland Puerto Rico Republic of Panama Republica Dominicana Russia Saudi Arabia Slovak Republic Slovenia South Africa Sri Lanka Switzerland Taiwan Thailand The Netherlands Trinidad,W.I. Tunisia Turkey UK Uruguay Vietnam

Nova Biomedical Stat Profile Prime Analyzer as follows: || PN 52855 Stat Profile Prime ABG Analyzer || PN 53655 Stat Profile Prime ABG Analyzer with Scanner || PN 52856 Stat Profile Prime CCS Analyzer || PN 53656 Stat Profile Prime CCS Analyzer with Scanner || PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner || PN 52857 Stat Profile Prime CCS Comp Analyzer || Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

All lots.

Blood Glucose Meter

PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG System with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer

Medical Device Safety Alert: Nova StatStrip and Nova StatSensor

Model Number: 52855, 53655, 52856, 53656, 53657, 52857 Serial Number: P07B15530

Diagnostic medical devices in vitro

Lot #/Exp.Date: 1010211346 12/31/2013 1020212032 02/28/2014 1020212100 04/30/2014 1020212101 04/30/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020411347 12/31/2013 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020611348 12/31/2013 1020712206 07/31/2014 1020811350 12/31/2013

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Nova Max Glucose Test Strips (50 Count Retail) || Catalog Number: 43437 || Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control

Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.

Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) || Catalog # 51493 (UK Only)

Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015  Expanded recall: Lot 0313021309, Expires 07/31/2015

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.

Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) || Catalog # 42214