Dear Valued Customer,

Transcription

1 BD Diagnostics Preanalytical Systems 1 Becton Drive Franklin Lakes, NJ USA tel: 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

2 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 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 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

3 North America x75mm 5.0ml Glass Serum Conventional Stopper x100mm 7.0ml Glass Serum Conventional Stopper x100mm 7.0ml Glass Serum Hemogard Stopper x75mm 4.0ml Plastic Serum Hemogard Stopper x100mm 6.0ml Plastic Serum Hemogard Stopper x75mm 3.0ml Plastic PST Hemogard Stopper x100mm 4.5ml Plastic PST Hemogard Stopper x100mm 8.0ml Plastic PST Conventional Stopper x75mm 4.0ml Plastic EDTA Hemogard Stopper x75mm 2.0ml Plastic EDTA Hemogard Stopper x75mm 3.0ml Plastic EDTA Hemogard Stopper x100mm 6.0ml Plastic EDTA Hemogard Stopper x100mm 6.0ml Plastic EDTA Hemogard Stopper x100mm 10.0ml Plastic EDTA Hemogard Stopper x75mm 3.0ml Plastic EDTA Conventional Stopper x100mm 7.0ml Glass EDTA Conventional Stopper x75mm 5.0ml Glass EDTA Conventional Stopper Page 1 of 6

4 Europe x75mm 5.0ml Glass Serum BD Hemogard Safety Closure x75mm 5.0ml Glass Serum BD Hemogard Safety Closure x75mm 5.0ml Glass Serum BD Hemogard Safety Closure x100mm 7.0ml Glass Serum BD Hemogard Safety Closure x100mm 7.0ml Glass Serum BD Hemogard Safety Closure x100mm 7.0ml Glass Serum BD Hemogard Safety Closure x75mm 4.0ml Plastic Serum BD Hemogard Safety Closure x75mm 4.0ml Plastic Serum BD Hemogard Safety Closure x100mm 6.0ml Plastic Serum BD Hemogard Safety Closure x100mm 6.0ml Plastic Serum BD Hemogard Safety Closure x100mm 10.0ml Plastic Serum BD Hemogard Safety Closure x100mm 10.0ml Plastic Serum BD Hemogard Safety Closure x75mm 3.0ml Plastic PST II BD Hemogard Safety Closure x75mm 3.0ml Plastic PST BD Hemogard Safety Closure x100mm 4.5ml Plastic PST II BD Hemogard Safety Closure x100mm 8.0ml Plastic PST II BD Hemogard Safety Closure x75mm 2.0ml Plastic EDTA BD Hemogard Safety Closure x75mm 3.0ml Plastic EDTA BD Hemogard Safety Closure x75mm 3.0ml Plastic EDTA BD Hemogard Safety Closure x75mm 4.0ml Plastic EDTA BD Hemogard Safety Closure x75mm 4.0ml Plastic EDTA BD Hemogard Safety Closure x75mm 4.0ml Plastic EDTA BD Hemogard Safety Closure x100mm 6.0ml Plastic EDTA BD Hemogard Safety Closure x100mm 10.0ml Plastic EDTA BD Hemogard Safety Closure x75mm 2.0ml Glass EDTA BD Hemogard Safety Closure x75mm 3.0ml Glass EDTA BD Hemogard Safety Closure x100mm 7.0ml Glass EDTA BD Hemogard Safety Closure x100mm 8.5ml Plastic SST II BD Hemogard Safety Closure x100mm 8.5ml Plastic SST II BD Hemogard Safety Closure x100mm 5.0ml Plastic SST II BD Hemogard Safety Closure x100mm 5.0ml Plastic SST II BD Hemogard Safety Closure x75mm 3.5ml Plastic SST II BD Hemogard Safety Closure x75mm 3.5ml Plastic SST II BD Hemogard Safety Closure x100mm 8.5ml Plastic SST II BD Hemogard Safety Closure x100mm 5.0ml Plastic SST II BD Hemogard Safety Closure x75mm 3.5ml Plastic SST II BD Hemogard Safety Closure Page 2 of 6

5 Asia Pacific x75mm 5.0ml Glass Serum Conventional Stopper x75mm 5.0ml Glass Serum BD Hemogard Stopper x75mm 3.0ml Glass Serum BD Hemogard Stopper x100mm 7.0ml Glass Serum BD Hemogard Stopper x100mm 7.0ml Glass Serum Conventional Stopper x75mm 4.0.ml Plastic Serum BD Hemogard Stopper x100mm 6.0ml Plastic Serum BD Hemogard Stopper x100mm 10.0ml Plastic Serum BD Hemogard Stopper x75mm 3.0ml Plastic PST II BD Hemogard Stopper x100mm 4.5ml Plastic PST II BD Hemogard Stopper x100mm 8.0ml Plastic PST II BD Hemogard Stopper x75mm 2.0ml Plastic EDTA BD Hemogard Stopper x75mm 4.0ml Plastic EDTA BD Hemogard Stopper x100mm 6.0ml Plastic EDTA BD Hemogard Stopper x100mm 6.0ml Plastic EDTA BD Hemogard Stopper x100mm 10.0ml Plastic EDTA BD Hemogard Stopper x75mm 3.0ml Glass EDTA Conventional Stopper x75mm 5.0ml Glass EDTA Conventional Stopper x100mm 10.0ml Glass EDTA Conventional Stopper x100mm 8.5ml Plastic SST II BD Hemogard Stopper x100mm 8.5ml Plastic SST II BD Hemogard Stopper x100mm 5.0ml Plastic SST II BD Hemogard Stopper x100mm 5.0ml Plastic SST II BD Hemogard Stopper x75mm 3.5ml Plastic SST II BD Hemogard Stopper x75mm 3.5ml Plastic SST II BD Hemogard Stopper x100mm 8.5ml Plastic SST II Conventional Stopper Page 3 of 6

6 Japan x75mm 5.0ml Glass Serum Conventional Stopper x100mm 7.0ml Glass Serum BD Hemogard Stopper x100mm 4.5ml Plastic PST BD Hemogard Stopper x75mm 3.0ml Plastic PST BD Hemogard Stopper x100mm 6.0ml Glass PST BD Hemogard Stopper x75mm 2.0ml Plastic EDTA BD Hemogard Stopper x75mm 2.0ml Plastic EDTA BD Hemogard Stopper x75mm 4.0ml Plastic EDTA BD Hemogard Stopper x75mm 2.0ml Plastic EDTA Conventional Stopper x100mm 8.5ml Plastic SST II BD Hemogard Stopper x100mm 5.0ml Plastic SST II BD Hemogard Stopper x75mm 3.5ml Plastic SST II BD Hemogard Stopper x100mm 8.5ml Plastic SST II BD Hemogard Stopper x100mm 5.0ml Plastic SST II BD Hemogard Stopper x100mm 8.5ml Plastic SST II Conventional Stopper x100mm 5.0ml Plastic SST II Conventional Stopper Central America x75mm 5.0 ml Glass Serum Conventional Stopper x100mm 7.0 ml Glass Serum Conventional Stopper x100mm 10.0 ml Glass Serum Conventional Stopper x75mm 4.0 ml Plastic Serum BD Hemogard Stopper x100mm 6.0 ml Plastic Serum BD Hemogard Stopper x100mm 6.0 ml Plastic Serum BD Hemogard Stopper x100mm 10.0 ml Plastic Serum Conventional Stopper Page 4 of 6

7 S. Latin America Brazil x75mm 3.0ml Glass Serum BD Hemogard Stopper x75mm 4.0ml Glass Serum BD Hemogard Stopper x75mm 5.0ml Glass Serum BD Hemogard Stopper x75mm 3.0ml Plastic PST II BD Hemogard Stopper x75mm 3.0ml Plastic EDTA BD Hemogard Stopper x75mm 5.0ml Glass EDTA BD Hemogard Stopper x100mm 8.5ml Plastic SST II BD Hemogard Stopper x100mm 5.0ml Plastic SST II BD Hemogard Stopper x75mm 3.5ml Plastic SST II BD Hemogard Stopper Argentina x100mm 6.0ml Glass Serum BD Hemogard Stopper x100mm 6.0ml Plastic Serum BD Hemogard Stopper x75mm 3.0ml Plastic PST II BD Hemogard Stopper x75mm 3.0ml Plastic EDTA BD Hemogard Stopper x75mm 5.0ml Glass EDTA BD Hemogard Stopper Chile x75mm 3.0ml Glass Serum BD Hemogard Stopper x75mm 5.0ml Glass Serum BD Hemogard Stopper x75mm 4.0ml Plastic Serum BD Hemogard Stopper x100mm 6.0ml Plastic Serum BD Hemogard Stopper x75mm 3.0ml Plastic PST II BD Hemogard Stopper x75mm 3.0ml Plastic EDTA BD Hemogard Stopper x75mm 5.0ml Glass EDTA BD Hemogard Stopper x100mm 8.5ml Plastic SST II BD Hemogard Stopper x75mm 3.5ml Plastic SST II BD Hemogard Stopper Page 5 of 6

8 S. Latin America Continued Peru/Ecuador/Bolivia x100mm 7.0ml Glass Serum BD Hemogard Stopper x75mm 3.0ml Plastic PST II BD Hemogard Stopper x75mm 3.0ml Plastic EDTA BD Hemogard Stopper x75mm 5.0ml Glass EDTA BD Hemogard Stopper N. Latin America Mexico x64mm 3.0ml Glass Serum Conventional Stopper x75mm 5.0ml Glass Serum BD Hemogard Stopper x100mm 7.0ml Glass Serum BD Hemogard Stopper x75mm 4.0ml Plastic Serum BD Hemogard Stopper x100mm 6.0ml Plastic Serum BD Hemogard Stopper x100mm 10.0 ml Plastic Serum Conventional Stopper x75mm 4.0ml Plastic EDTA BD Hemogard Stopper x75mm 5.0ml Glass EDTA Conventional Stopper Colombia x64mm 3.0ml Glass Serum Conventional Stopper x75mm 5.0ml Glass Serum Conventional Stopper x100mm 7.0ml Glass Serum Conventional Stopper x75mm 4.0ml Plastic Serum BD Hemogard Stopper x100mm 6.0ml Plastic Serum BD Hemogard Stopper Venezuela x64mm 3.0ml Glass Serum Conventional Stopper x100mm 7.0ml Glass Serum Conventional Stopper x75mm 3.0ml Plastic Serum Conventional Stopper x75mm 4.0ml Plastic Serum BD Hemogard Stopper Page 6 of 6