| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00387-1 |
| Product Name/Description |
ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
Catalogue Numbers: 02419937 (116734) and 03896216 (116735) respectively
Siemens Material Numbers (SMN): 10333349 and 10334837 respectively
All Lot Numbers
Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT
ARTG Number: 175636 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. (This only occurs when the Syphilis assay immediately precedes the BR assay on the ADVIA Centaur, ADVIA Centaur XP or ADVIA Centaur XPT systems.) Syphilis interference may cause controls to recover low out of range for the ADVIA Centaur BR assay. Siemens evaluated BR patient samples within the analytical measuring range and BR samples above the analytical measuring range (> 450 U/mL) between 5,875 U/mL & 11,443 U/mL. ADVIA Centaur BR patient samples below 221 U/mL are unaffected. ADVIA Centaur BR patient samples above the analytical measuring range may recover on curve as low as 200 U/mL. A falsely low result during serial monitoring of treatment response when the true value is stable/increasing may lead to a delay in detection of cancer progression.
Current & future lots of ADVIA Centaur Systems BR reagents are affected until implementation of a solution. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is requesting customers to refer to their recall notification letter to ascertain the ways their system is affected and to follow the appropriate instructions on how to correct their systems. Customers are advised to immediately contact their local Siemens Customer Care Centre or their local Siemens technical support representative, if they have received complaints of illness or adverse events associated with the products. Customers are further advised to review the recall notification letter with their medical director.
This action has been closed out on 30/01/2020 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |