Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00693-1 |
Product Name/Description |
ADVIA Chemistry Systems, Alkaline Phosphate (ALPAMP) Reagent Kits
Catalogue Number: 03035814
Siemens Material Number: 10309049
Lot Numbers: 267774 & 271674
Expiration Date: 2013-12
ARTG Number: 176331 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
9/07/2013 |
Responsible Entity |
|
Reason/Issue |
Siemens has confirmed that the affected lots demonstrate an increased incidence of absorbance flags (u, U) and //// errors. |
Recall Action |
Recall |
Recall Action Instructions |
Siemens is requesting their customers to discontinue use and discard any reagents from the affected lot. Kits will be replaced at no charge. A look back at previously reported results is at the discretion of the testing laboratory. |
Contact Information |
1800 310 300 - Siemens Technical Support Centre |