Dear Valued Customer,

BD Diagnostics Preanalytical Systems 1 Becton Drive Franklin Lakes, NJ 07417-1885 USA tel: 201.847.6800 www.bd.com TECHNICAL BULLETIN Date: September 23, 2004 To: users of all variants of BD Vacutainer SST glass and Plus plastic tubes Subject: Immunoassay Interferences Dear Valued Customer, We would like to take the opportunity to update you on the issue we have been working to resolve regarding immunoassay interferences when using all variants of BD Vacutainer SST glass and Plus plastic tubes on select instrument systems. This global communication supplements preceding communications from both the individual instrument companies and BD that were sent to the customers of the instrument platforms listed below. The table below provides a summary of the systems and specific assays involved: Instrument Company, System Abbott Diagnostics AUSZYME Monoclonal Assay Bayer Healthcare Diagnostics Division ADVIA Centaur, ACS:180. Note: Bayer has confirmed that they have completed testing of their assays. Beckman Coulter, Inc. Access, Access 2, UniCel DxI 800, SYNCHRON LX I 725 Diagnostics Products Corporation (DPC) IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2500 Specific Assays Cited Hepatitis B Surface Antigen (HBsAg) increased initial and/or repeat reactive rate, 3-20% Total T3, 27% avg. + bias Total T4, 18% avg. + bias Folate BA, 32% avg. + bias VB 12, 38% avg. + bias BR, 19% avg. + bias FSH, 26% avg. - bias Total T3, up to 50% + bias Total T3, 20-30% + bias Total T4, 20-30% + bias Cortisol, 20-30% + bias Interim Tube Solutions (See attachment for catalog numbers) BD Vacutainer serum tubes (glass or plastic) without gel separator BD Vacutainer EDTA tubes (glass or plastic) BD Vacutainer PST Plus tubes For all cited assays: BD Vacutainer serum tubes (glass or plastic) without gel separator BD Vacutainer serum tubes (glass or plastic) without gel separator Total T3: BD Vacutainer plastic serum tube without gel separator (Note: In development of its package insert reference range for Total T3, DPC has taken into consideration the observed difference between glass and plastic BD Vacutainer serum tubes without gel separator. Glass serum tubes may be used for this assay if the users have established their own reference range using a glass serum tube.) Total T4 and Cortisol: BD Vacutainer serum tube (glass or plastic) without gel separator BD Vacutainer SST II tube

When interpreting the results of these assays, you are advised to do so in the context of other laboratory test results, as well as the patients clinical presentation. BD is working collaboratively with each of these instrument companies to resolve this issue. BD scientists and engineers are in the process of validating product that restores clinical performance on these platforms. BD s validation practices will also ensure the ongoing performance of our products on unaffected systems. We will keep you apprised of our progress as additional information becomes available. Current updates can be obtained at www.bd.com/vacutainer. Additional information on these tubes and affected systems can be obtained through your local BD representative. The attached tables provide specific catalog numbers for the interim tube solutions referenced above. We can also be contacted via e-mail at Vacutainer_TechServices@BD.com. We also advise that you contact your respective instrument system manufacturer for any information regarding potential interferences. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. We further apologize for any inconvenience this may cause you. We have taken this action in accordance with our continued commitment to provide you with superior products and services. Thank you for your patience and support as we work to resolve this issue. Sincerely, Ana K. Stankovic, MD, PhD, MSPH Worldwide Medical Director BD Diagnostics - Preanalytical Systems John D. Boselli, PE WW VP Quality Management and Regulatory Compliance BD Diagnostics - Preanalytical Systems Attachment: BD Vacutainer catalog numbers VS 7313 Becton, Dickinson and Company

North America 366434 13x75mm 5.0ml Glass Serum Conventional Stopper 366431 13x100mm 7.0ml Glass Serum Conventional Stopper 369615 13x100mm 7.0ml Glass Serum Hemogard Stopper 367812 13x75mm 4.0ml Plastic Serum Hemogard Stopper 367815 13x100mm 6.0ml Plastic Serum Hemogard Stopper 367960 13x75mm 3.0ml Plastic PST Hemogard Stopper 367962 13x100mm 4.5ml Plastic PST Hemogard Stopper 367964 16x100mm 8.0ml Plastic PST Conventional Stopper 367861 13x75mm 4.0ml Plastic EDTA Hemogard Stopper 367841 13x75mm 2.0ml Plastic EDTA Hemogard Stopper 367856 13x75mm 3.0ml Plastic EDTA Hemogard Stopper 367899 13x100mm 6.0ml Plastic EDTA Hemogard Stopper 367863 13x100mm 6.0ml Plastic EDTA Hemogard Stopper 366643 16x100mm 10.0ml Plastic EDTA Hemogard Stopper 367835 13x75mm 3.0ml Plastic EDTA Conventional Stopper 366450 13x100mm 7.0ml Glass EDTA Conventional Stopper 366452 13x75mm 5.0ml Glass EDTA Conventional Stopper Page 1 of 6

Europe 367643 13x75mm 5.0ml Glass Serum BD Hemogard Safety Closure 367614 13x75mm 5.0ml Glass Serum BD Hemogard Safety Closure 367624 13x75mm 5.0ml Glass Serum BD Hemogard Safety Closure 367625 13x100mm 7.0ml Glass Serum BD Hemogard Safety Closure 367694 13x100mm 7.0ml Glass Serum BD Hemogard Safety Closure 367615 13x100mm 7.0ml Glass Serum BD Hemogard Safety Closure 368975 13x75mm 4.0ml Plastic Serum BD Hemogard Safety Closure 369032 13x75mm 4.0ml Plastic Serum BD Hemogard Safety Closure 367837 13x100mm 6.0ml Plastic Serum BD Hemogard Safety Closure 368815 13x100mm 6.0ml Plastic Serum BD Hemogard Safety Closure 367895 16x100mm 10.0ml Plastic Serum BD Hemogard Safety Closure 367896 16x100mm 10.0ml Plastic Serum BD Hemogard Safety Closure 367374 13x75mm 3.0ml Plastic PST II BD Hemogard Safety Closure 368497 13x75mm 3.0ml Plastic PST BD Hemogard Safety Closure 367376 13x100mm 4.5ml Plastic PST II BD Hemogard Safety Closure 367378 16x100mm 8.0ml Plastic PST II BD Hemogard Safety Closure 367836 13x75mm 2.0ml Plastic EDTA BD Hemogard Safety Closure 368857 13x75mm 3.0ml Plastic EDTA BD Hemogard Safety Closure 368856 13x75mm 3.0ml Plastic EDTA BD Hemogard Safety Closure 368861 13x75mm 4.0ml Plastic EDTA BD Hemogard Safety Closure 368860 13x75mm 4.0ml Plastic EDTA BD Hemogard Safety Closure 367839 13x75mm 4.0ml Plastic EDTA BD Hemogard Safety Closure 367864 13x100mm 6.0ml Plastic EDTA BD Hemogard Safety Closure 367525 16x100mm 10.0ml Plastic EDTA BD Hemogard Safety Closure 367651 13x75mm 2.0ml Glass EDTA BD Hemogard Safety Closure 367652 13x75mm 3.0ml Glass EDTA BD Hemogard Safety Closure 367655 13x100mm 7.0ml Glass EDTA BD Hemogard Safety Closure 367958 16x100mm 8.5ml Plastic SST II BD Hemogard Safety Closure 367953 16x100mm 8.5ml Plastic SST II BD Hemogard Safety Closure 367954 13x100mm 5.0ml Plastic SST II BD Hemogard Safety Closure 367955 13x100mm 5.0ml Plastic SST II BD Hemogard Safety Closure 367956 13x75mm 3.5ml Plastic SST II BD Hemogard Safety Closure 367957 13x75mm 3.5ml Plastic SST II BD Hemogard Safety Closure 366644 16x100mm 8.5ml Plastic SST II BD Hemogard Safety Closure 366566 13x100mm 5.0ml Plastic SST II BD Hemogard Safety Closure 368498 13x75mm 3.5ml Plastic SST II BD Hemogard Safety Closure Page 2 of 6

Asia Pacific 366434 13x75mm 5.0ml Glass Serum Conventional Stopper 369614 13x75mm 5.0ml Glass Serum BD Hemogard Stopper 369612 13x75mm 3.0ml Glass Serum BD Hemogard Stopper 369615 13x100mm 7.0ml Glass Serum BD Hemogard Stopper 366431 13x100mm 7.0ml Glass Serum Conventional Stopper 367812 13x75mm 4.0.ml Plastic Serum BD Hemogard Stopper 367815 13x100mm 6.0ml Plastic Serum BD Hemogard Stopper 367896 16x100mm 10.0ml Plastic Serum BD Hemogard Stopper 367373 13x75mm 3.0ml Plastic PST II BD Hemogard Stopper 367375 13x100mm 4.5ml Plastic PST II BD Hemogard Stopper 367377 16x100mm 8.0ml Plastic PST II BD Hemogard Stopper 367841 13x75mm 2.0ml Plastic EDTA BD Hemogard Stopper 367839 13x75mm 4.0ml Plastic EDTA BD Hemogard Stopper 367863 13x100mm 6.0ml Plastic EDTA BD Hemogard Stopper 367941 13x100mm 6.0ml Plastic EDTA BD Hemogard Stopper 367525 16x100mm 10.0ml Plastic EDTA BD Hemogard Stopper 366437 13x75mm 3.0ml Glass EDTA Conventional Stopper 366452 13x75mm 5.0ml Glass EDTA Conventional Stopper 366457 16x100mm 10.0ml Glass EDTA Conventional Stopper 367958 16x100mm 8.5ml Plastic SST II BD Hemogard Stopper 367953 16x100mm 8.5ml Plastic SST II BD Hemogard Stopper 367954 13x100mm 5.0ml Plastic SST II BD Hemogard Stopper 367955 13x100mm 5.0ml Plastic SST II BD Hemogard Stopper 367956 13x75mm 3.5ml Plastic SST II BD Hemogard Stopper 367957 13x75mm 3.5ml Plastic SST II BD Hemogard Stopper 368972 16x100mm 8.5ml Plastic SST II Conventional Stopper Page 3 of 6

Japan 366434 13x75mm 5.0ml Glass Serum Conventional Stopper 369615 13x100mm 7.0ml Glass Serum BD Hemogard Stopper 367963 13x100mm 4.5ml Plastic PST BD Hemogard Stopper 367960 13x75mm 3.0ml Plastic PST BD Hemogard Stopper 367794 13x100mm 6.0ml Glass PST BD Hemogard Stopper 367846 13x75mm 2.0ml Plastic EDTA BD Hemogard Stopper 367845 13x75mm 2.0ml Plastic EDTA BD Hemogard Stopper 367862 13x75mm 4.0ml Plastic EDTA BD Hemogard Stopper 367840 13x75mm 2.0ml Plastic EDTA Conventional Stopper 367953 16x100mm 8.5ml Plastic SST II BD Hemogard Stopper 367955 13x100mm 5.0ml Plastic SST II BD Hemogard Stopper 367957 13x75mm 3.5ml Plastic SST II BD Hemogard Stopper 367528 16x100mm 8.5ml Plastic SST II BD Hemogard Stopper 368640 13x100mm 5.0ml Plastic SST II BD Hemogard Stopper 368972 16x100mm 8.5ml Plastic SST II Conventional Stopper 367520 13x100mm 5.0ml Plastic SST II Conventional Stopper Central America 366434 13x75mm 5.0 ml Glass Serum Conventional Stopper 366431 13x100mm 7.0 ml Glass Serum Conventional Stopper 366430 16x100mm 10.0 ml Glass Serum Conventional Stopper 367812 13x75mm 4.0 ml Plastic Serum BD Hemogard Stopper 367815 13x100mm 6.0 ml Plastic Serum BD Hemogard Stopper 367819 13x100mm 6.0 ml Plastic Serum BD Hemogard Stopper 367820 16x100mm 10.0 ml Plastic Serum Conventional Stopper Page 4 of 6

S. Latin America Brazil 367612 13x75mm 3.0ml Glass Serum BD Hemogard Stopper 367793 13x75mm 4.0ml Glass Serum BD Hemogard Stopper 369614 13x75mm 5.0ml Glass Serum BD Hemogard Stopper 367374 13x75mm 3.0ml Plastic PST II BD Hemogard Stopper 367856 13x75mm 3.0ml Plastic EDTA BD Hemogard Stopper 367653 13x75mm 5.0ml Glass EDTA BD Hemogard Stopper 367958 16x100mm 8.5ml Plastic SST II BD Hemogard Stopper 367955 13x100mm 5.0ml Plastic SST II BD Hemogard Stopper 367957 13x75mm 3.5ml Plastic SST II BD Hemogard Stopper Argentina 369794 13x100mm 6.0ml Glass Serum BD Hemogard Stopper 367815 13x100mm 6.0ml Plastic Serum BD Hemogard Stopper 367374 13x75mm 3.0ml Plastic PST II BD Hemogard Stopper 367856 13x75mm 3.0ml Plastic EDTA BD Hemogard Stopper 367653 13x75mm 5.0ml Glass EDTA BD Hemogard Stopper Chile 369612 13x75mm 3.0ml Glass Serum BD Hemogard Stopper 369614 13x75mm 5.0ml Glass Serum BD Hemogard Stopper 367812 13x75mm 4.0ml Plastic Serum BD Hemogard Stopper 367815 13x100mm 6.0ml Plastic Serum BD Hemogard Stopper 367374 13x75mm 3.0ml Plastic PST II BD Hemogard Stopper 367856 13x75mm 3.0ml Plastic EDTA BD Hemogard Stopper 367653 13x75mm 5.0ml Glass EDTA BD Hemogard Stopper 367958 16x100mm 8.5ml Plastic SST II BD Hemogard Stopper 367957 13x75mm 3.5ml Plastic SST II BD Hemogard Stopper Page 5 of 6

S. Latin America Continued Peru/Ecuador/Bolivia 369615 13x100mm 7.0ml Glass Serum BD Hemogard Stopper 367374 13x75mm 3.0ml Plastic PST II BD Hemogard Stopper 367856 13x75mm 3.0ml Plastic EDTA BD Hemogard Stopper 367653 13x75mm 5.0ml Glass EDTA BD Hemogard Stopper N. Latin America Mexico 366381 10.25x64mm 3.0ml Glass Serum Conventional Stopper 369614 13x75mm 5.0ml Glass Serum BD Hemogard Stopper 368124 13x100mm 7.0ml Glass Serum BD Hemogard Stopper 367812 13x75mm 4.0ml Plastic Serum BD Hemogard Stopper 368175 13x100mm 6.0ml Plastic Serum BD Hemogard Stopper 367820 16x100mm 10.0 ml Plastic Serum Conventional Stopper 368171 13x75mm 4.0ml Plastic EDTA BD Hemogard Stopper 366352 13x75mm 5.0ml Glass EDTA Conventional Stopper Colombia 366381 10.25x64mm 3.0ml Glass Serum Conventional Stopper 366434 13x75mm 5.0ml Glass Serum Conventional Stopper 366431 13x100mm 7.0ml Glass Serum Conventional Stopper 367812 13x75mm 4.0ml Plastic Serum BD Hemogard Stopper 367815 13x100mm 6.0ml Plastic Serum BD Hemogard Stopper Venezuela 366381 10.25x64mm 3.0ml Glass Serum Conventional Stopper 366431 13x100mm 7.0ml Glass Serum Conventional Stopper 366668 13x75mm 3.0ml Plastic Serum Conventional Stopper 367812 13x75mm 4.0ml Plastic Serum BD Hemogard Stopper Page 6 of 6