| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00310-1 |
| Product Name/Description |
ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro diagnostic medical device (IVD)
Catalogue Number: SMN 10312270
Lot Numbers: 74264,73839, 57211
Expiration Date: 31/7/19
ARTG Number: 184207
(Siemens Healthcare - Haematology full blood count IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that Platelet Clump Flags (PLT-CLM) are generated in the Perox channel of the ADVIA 120/2120/2120i Haematology System while running CBC/DIFF (Complete Blood Count / Differential) whole blood samples with DIFF TIMEPAC Perox 1 reagent lot # 57211, in samples without platelet clumps.
The accuracy of the platelet results are not impacted when the Perox 1 reagent (lot 57211) is used on the system and a PLT-CLM flag is generated due to this issue. Additionally, platelet results are reported from the Red Blood Cell/Platelet (RBC/PLT) channel and NOT measured in the Perox Channel where Platelet Clumps are detected. However, the Platelet results will be flagged if the Clump Count is greater than 300, directing the user to investigate the sample. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting customers discontinue use of and discard the entire lot of ADVIA 120/2120/2120i DIFF TIMEPAC products listed in Table 1 of the Customer Letter. Complete and return the Response Form attached to the Customer Letter by Friday 20th April 2018 as confirmation that you have received and understood this Recall Action.
This action has been closed out on 12/09/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |