TRACERlab Mx

Customer information (DOC0284097)

Preventive check of Aluminum caps crimping to avoid leakage due
to insufficient crimping of ABX Reagents Kit vials.
Class A

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Template #: FIRPFM.75.12.U01f
Template Revision: 1
Template author: ABt
Copyrighted © by GE Healthcare, 2006
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GE Healthcare TRACERlab Mx Customer information

Table of Contents
1. Introduction and Objectives.................................................................................. 4
2. Customer Information................................................................................................ 4

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GE Healthcare TRACERlab Mx Customer information

1. Introduction and Objectives

This information applies to Radiopharmacy TRACERlab MX and the TL Mx-FDG Reagents kit from ABX
“GE TRACERlab MXFDG Synthesizer Reagents Kit”.

2. Customer Information
This publication is valid until its next revision or until implemented in the affected Direction/s.

ABX Reagents Kit’s vials may be equipped with an inexact crimping of the aluminum caps; this may
cause leakage and also affect the yield.

Please verify that the aluminum caps are correctly crimped on the vial by a manual twist; Retain the vial
by hand and gently attempt to twist the aluminum cap, if cap can be twisted the crimping is to be
considered as insufficient.

WARNNG!
ƒ Handle glass vials with precautions.
ƒ Avoid spillage; vials may contain solvent or caustic, in case of spillage please refer to the
appropriate MSDS.
ƒ Use adapted PPE, personal protective equipment.

Op: Action: Perf. By

1. Open the ABX Reagents Kit and perform the twist test before placing the
different vials on the MX-FDG cassette (please refer to pictures 2-1 and 2-
2 during this Op).
ƒ If no twisting is present; Crimping is to be considered as adequate,
proceed with the next synthesize step in accordance with the SOP.
ƒ If twisting is present; Crimping is to be considered as defective and subject
Reagents Kit should be forwarded to GE (Belgium, Liege site) or directly to
your ABX Reagents Kit supplier (please refer to table 2-1).
Table 2-1
Reagents kit return addresses
GE Medical Systems Benelux s.a ABX Biomedizinische Forschungsreagenzien
Rue Marie Curie, 78 H.-Gläser-strasse 10-14
B-4431 Loncin (Liege) D-01454 Raderberg
BELGIUM GERMANY

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GE Healthcare TRACERlab Mx Customer information
Picture 2-1
ABX Reagent vials prior to twist test

Picture 2-2
ABX Reagent vials Post twist test

Twisted CAP

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GE Healthcare
www.gehealthcare.com
GE Medical Systems Benelux s.a
Rue Marie Curie, 78
B-4431 Loncin (Liege)
BELGIUM
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TRACERlab Mx Customer information
WARRANTY AND LIABILITY
GE Healthcare (GEHC) does not accept liability for injury to personnel or
damage to equipment that may result from misuse of this equipment,
failure to observe the hazard notices contained in this publication, or
failure to observe federal, state and/or local regulations.
Whilst every effort has been made to ensure the technical accuracy of
this publication, the information contained herein is subject to change
without notice. GEHC makes no warranty of any kind with regard to this
material.
GEHC shall not be liable for errors contained herein, or for incidental or
consequential damages arising from the use of the equipment described
in this documentation.
Copyright© 2006 by General Electric Company inc. All rights
reserved.
Property of GE. No Rights Licensed - Do not duplicate. Disclosure to
Third Parties Prohibited.