Item # 1.15112.0001 Lot # OC553145

Immunology and Microbiology Devices

1

No

Product was only sent to one US customer: Becton Dickinson, Cayey. Pureto Rico.

Anaerotest;Microbiology , || 50 test strips || 1.15112 || Store dry and tightly closed. || Store at + 15 C to +25C || Merck IVD || 64271 Darmstadt, Germany

Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001

Immunology and Microbiology Devices

2

No

All product was shipped to St. Louis, MO

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

Reference: 412434 Lots: 1004331500, 1004271120, || 1004178060, 1003977300, 1003697470, 1003415090, || 1003276060, 1003069230, 1002488490, 1001936360.

Immunology and Microbiology Devices

In vitro antimicrobial susceptibility strips of pathogens isolated from samples of human origin

Lot #050723

Immunology and Microbiology Devices

2

No

World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.

APhL¿ HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc.-- (current address now in Seabrook, TX 77586).

Lot #050723

Immunology and Microbiology Devices

2

No

World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.

APhL¿ HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).

Lot #050723

Immunology and Microbiology Devices

2

No

World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.

APhL¿ HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).

List 6L21-25, lot 93794HN00, expiration date 2011-09-15

Immunology and Microbiology Devices

2

No

Nationwide Distribution including Puerto Rico

ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25

LIst 6E59, Versions 22.0 and below, Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100, 54701P100, 50449P100, 52151P100, 54692P100

Immunology and Microbiology Devices

2

No

International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Thailand, Uruguay and Venezuela. There were no USA accounts.

ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA

list 02K43-01, lot number V96128

Immunology and Microbiology Devices

2

No

Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea

ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

Lot M305283

Immunology and Microbiology Devices

1

No

Array Systems Calibrator 5 || Part No. 465250

AN1 (100 dose) Lot #022206 - 16404-100, Exp. Date: August 22, 2006, and AN5 (20 dose) Lot #022206 - 16404-20, Exp. Date: August 22, 2006.

Immunology and Microbiology Devices

1

No

The recalled product was distributed to direct account/customers located in CA, CO, GA, IL, NE, OH , PR and TX.

Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well''. The product is distributed by and/or manufactured by BEC Laboratories, Inc., 705 Front Street, Toledo, OH 43605.

list 05C36; lots 49454M200, 50006M100, 51129M100, 51130M100

Immunology and Microbiology Devices

3

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 03C74; lot 45304M200, 45304M201

Immunology and Microbiology Devices

3

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 03B41- lot 49467M200

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 03B42; lots 48100M200, 50118M100, 50152M200

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 04B47;48069M200

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 05C78; lots 48839M100, 50450M100, 51252M100

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 08B88; lot 49633M100

Immunology and Microbiology Devices

3

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 08B89; lot 50589M100

Immunology and Microbiology Devices

3

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 08D21-20; lots 48132M200, 48139M200, 51069M100

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 05E20; lot 48466M100, 50410M200

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 09B01; lots 49492M200, 50261M100, 50672M100

Immunology and Microbiology Devices

3

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 03E43; lot 48718M100

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 03B23; lot 49146M100

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 04B46; 50061M100

Immunology and Microbiology Devices

2

No

Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064