| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00247-1 |
| Product Name/Description |
ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).
ADVIA Chemistry Lactate Dehydrogenase L-P
Test Code: LDLP
Reference Numbers: 07502115 (40 mL) & 03029628 (70 mL)
Siemens Material Numbers: 10309501 (40mL) & 10341128 (70 mL)
ADVIA Chemistry Lactate Dehydrogenase P-L
Test Code: LDPL
Reference Numbers: 07502999 (40 mL) & 03030863 (70 mL)
Siemens Material Numbers: 10309502 (40 mL) & 10341129 (70 mL)
All Lots
ARTG Number: 176331 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics is providing an update to all ADVIA Chemistry Systems Lactate Dehydrogenase L-P (LDLP) and Lactate Dehydrogenase P-L (LDPL) assay Instructions For Use (IFU). The current intended use section within in the ADVIA Chemistry Systems Lactate Dehydrogenase IFU document contains the following statements which will be removed (given these assays are not validated to monitor for cancer therapy):
"ADVIA Chemistry LDLP: They may also be used to monitor cancer therapy.
ADVIA Chemistry LDPL: They may also be used to monitor extensive cancer and cancer therapy." |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to refer to the revised intended use statement in the notification in order to use the assays as defined. Users will be provided with the updated IFU when it becomes available.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |