list 03B22; lot 49109M100

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 Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

list 04B25; lot 49114M100

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 Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

All Models

Immunology and Microbiology Devices

1

No

Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

BacT/ALERT 3D 60 Systems Software, Blood Culturing System

Lot number 1013177 (Product No. 259790)

Immunology and Microbiology Devices

1

No

Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.

bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790

All codes associated with the product.

Immunology and Microbiology Devices

1

No

Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK.

BacT/ALERT¿(BTA) Classic instruments.

Catalog number: 259791, Lot umber 1027481, Expiry: December 8, 2011

Immunology and Microbiology Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of China, Tokyo, South Korea, Canada, Sweden, Austria, Poland, and Belgium

BacT/ALERT - FA Reagent Bottle || The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacterial and fungi) from blood and other normally sterile body fluids.

Catalog # 441385-Serial numbers: FT-0001 to FT-0906 and FT-0922

Immunology and Microbiology Devices

1

No

Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.

BACTEC" FX Instrument-Top, catalog #441385. || The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.

Catalog # 441398-Serial numbers:V100E, V101F, V200B, V210A, V220B, V221A, and V230B  Catalog # 441750-Serial number: V100A

Immunology and Microbiology Devices

1

No

Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.

BACTEC" FX System Software, catalog #441398 and #441750 || The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.

Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266

Immunology and Microbiology Devices

1

No

Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.

Batteries used with the LIFEPAK 20 defibrillator/monitor

Lot number: 4153588 and Expiration date: September 23, 2004

Immunology and Microbiology Devices

2

No

83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

BBL Brain Heart Infusion Agar CC w/Sheep Blood - Catalog Number 296178.

Lot number: 4146359 and Expiration date: August 02, 2004

Immunology and Microbiology Devices

2

No

83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

BBL Brain Heart Infusion Agar w/10% Sheep Blood - Catalog Number 297655.

Lot number: 4154491 and Expiration date: August 19, 2004

Immunology and Microbiology Devices

2

No

83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

BBL Columbia C.N.A. Agar w/5% Sheep Blood - Catalog Number 297831.

Lot number: 4153593 and Expiration date: August 26, 2004

Immunology and Microbiology Devices

2

No

83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB - Catalog Number 295618.

Oxidase kit - lot 2222008 with expiration date 08/31/13

Immunology and Microbiology Devices

1

No

Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.

BBL DrySlide Oxidase Kit, catalog number 231746 || Product Usage: || Presumptive diagnostic aid for gram-negative bacteria.

PYR kit - lot 2276481 with expiration date 09/30/13

Immunology and Microbiology Devices

1

No

Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.

BBL DrySlide PYR Kit, catalog number 231747 || Product Usage: || Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.

BBL¿ GasPak¿ Pouch System  Batch Expiration   Date 5214643 08/31/06 5214642 08/31/06 5214640 08/31/06 5194865 08/31/06 5194863 08/31/06 5189360 07/31/06 5189359 07/31/06 5189358 07/31/06 5189357 07/31/05 5189356 07/31/06 5189355 07/31/06 5189353 07/31/06 5182704 07/31/06 5182703 07/31/06 5182702 07/31/06 5182701 07/31/06 5165500 06/30/06 5165499 06/30/06 5165496 06/30/06 5165494 06/30/06 5165491 06/30/06 5158860 06/30/06 5154612 06/30/06 5154610 06/30/06 5152966 06/30/06 5152958 06/30/06 5146724 06/30/06 5126942 05/31/06 5119623 05/31/06 5119622 05/31/06 5119621 05/31/06 5119620 05/31/06 5119619 05/31/06 4345515 12/31/06 5097847 04/30/06 5097845 04/30/06 5097841 04/30/06 5097838 04/30/06 5097837 04/30/06 5074202 03/31/06 5074200 03/31/06 5074198 03/31/06 5069662 03/31/06 5069660 03/31/06 5069659 03/31/06 5061870 03/31/06 5061866 03/31/06 5056474 03/31/06 5056472 03/31/06 5056471 03/31/06 5052074 01/31/06 5052071 01/31/06 5052070 01/31/06 5048914 01/31/06 5040337 01/31/06 5040336 01/31/06 5035915 01/31/06 5035914 01/31/06 5032185 01/31/06 5032184 01/31/06 5031047 01/31/06 5031045 01/31/06 5028254 01/31/06 5021661 01/31/06 5019413 01/31/06 5019411 01/31/06 5013255 01/31/06 5013253 01/31/06 5010278 01/31/06 5010276 01/31/06 5010274 01/31/06 4365412 01/31/06 4355778 12/31/05 4355774 12/31/05 4355771 12/31/05 4352493 12/31/05 4345533 12/31/05 4345531 12/31/05 4345521 12/31/05 4345518 12/31/05 4345515 12/31/05 4343926 12/31/05 4343923 12/31/05 4343922 12/31/05 4341958 11/30/05 4338027 11/30/05 4338025 11/30/05 4338023 11/30/05 4324272 11/30/05 4324271 11/30/05 4324269 11/30/05 4324267 11/30/05 4316041 11/30/05 4316036 11/30/05 4316035 11/30/05 4316033 11/30/05 4316030 11/30/05 4316029 11/30/05 4315197 11/30/05 4315194 11/30/05 4315192 11/30/05 4303939 11/30/05 4303937 11/30/05 4303933 11/30/05 4303932 11/30/05 ********************************************************************************************************* BBL¿ GasPak¿ CampyPouch¿ System  Batch Expiration Date  5164299 8/31/2006 5158868 6/30/2006 5158867 6/30/2006 5158866 6/30/2006 5129239 5/31/2006 5126951 5/31/2006 5126949 5/31/2006 5126947 5/31/2006 5104863 4/30/2006 5104862 4/30/2006 5104859 4/30/2006 5063685 3/31/2006 5063687 3/31/2006 5063684 3/31/2006 5055069 3/31/2006 5048900 2/28/2006 5046481 2/28/2006 5046480 2/28/2006 5042726 2/28/2006 5042721 2/28/2006 5024692 1/31/2006 5024129 1/31/2006 5024120 1/31/2006 5024692 1/31/2006 4335944 12/31/2005 4335943 12/31/2005 4335938 12/31/2005 4335940 12/31/2005 4335932 12/31/2005 4335935 12/31/2005 4303906 11/30/2005 4303857 11/30/2005

Immunology and Microbiology Devices

1

No

Product was distributed to direct accounts and distributors nationwide and to international affiliated distributors.

BBL¿ GasPak¿ Pouch System and BBL¿ GasPak¿ CampyPouch¿ System, Catalog numbers 260651 and 260656, packed in boxes of 25

Lot 1034119 Exp. 2011/05/03

Immunology and Microbiology Devices

2

No

Worldwide Distribution--USA (nationwide) and the countries of Canada, Columbia, Jamaica, South Korea, and Taiwan.

BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. || Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing.

Lot numbers: 3129508 exp 1/30/04 3129509 exp 2/3/04 3129506 exp 2/3/04 3129512 exp 2/3/04

Immunology and Microbiology Devices

1

No

Product was sold to 11 distributors and one end user in the US. Product was additionally distributed to firm''s subsidiaries in Canada and Europe.

BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.

Lot number: 4153582 and Expiration date: September 09, 2004

Immunology and Microbiology Devices

2

No

83 (76 end-users, 3 international BD facilities and 4 distributors) worldwide.

BBL TSA II w/5% Sheep Blood, Spacesaver - Catalog Number 292537.

Lot Number / Exp. Date 16629910 April 30, 2007-Cat # 240952 16562410 April 30, 2007-Cat # 240952 16629920 April 30, 2007-Cat # 240953 16562420 April 30, 2007-Cat # 240953

Immunology and Microbiology Devices

1

No

Worldwide-product was sold to distributors and end users

BD¿ BBL¿ Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.

Lot number 2089253

Immunology and Microbiology Devices

2

No

Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico

BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

Catalogue #241049, Lot #2192837, 3029141, 2116596, 3029124 & 2092005

Immunology and Microbiology Devices

2

No

Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan

BD, Brucella abortus Antigen

Catalogue #240943, Lot #3046337

Immunology and Microbiology Devices

2

No

Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan

BD, Brucella melitensis Antigen

Catalogue #240934, Lot #3210932

Immunology and Microbiology Devices

2

No

Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan

BD, Brucella Postive Control Antiserum (AMS)

Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)

Immunology and Microbiology Devices

2

No

US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.

BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 || Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.