Reagent

All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.

Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) || Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.

Lot numbers 078011, 088061, 098091, 109011, 119021, 129031, 139051, 139051A

Immunology and Microbiology Devices

2

No

Product was distributed to 123 consignees throughout the US.

PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 10-112, 10-0113, and 10-115 Advia test kit, manufactured by DiaDexus, South San Francisco, CA.

list 1L77-25, lot number 86599M500, expiration date September 01, 2011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA and countries including Puerto Rico, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Montenegro, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Vietnam.

Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 1L77-25 || The Architect Tacrolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.

list 1P30-25, all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: Throughout USA, including Puerto Rico, and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom and Vietnam.

ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25 || The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

Lot numbers: 991112, 991346, 991584, 991857, 992115, 992359, 992458, 992854 were manufactured at: Beckman Coulter, Diagnostics Systems Laboratories, a Beckman Coulter Company, 445 West Medical Center Blvd, Webster, Texas 77598.  Lot numbers: 100115A, 100205A, 100205RA, 100226A, 100226RA, 100319A, 100319RA, 100409A, 100409RA, 100430A, 100430RA, 100521A, 100611A, 100611RA, 100702A, 100723A, 100723B, 100723RA, 100813A, 100813RB, 100813C were manufactured at: Immunotech, Prague, a Beckman Coulter Company, Radiova 1, Praha, 10227, Czech Republic.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.

DHEA RIA Reagent || The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use.