| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00002-1 |
| Product Name/Description |
Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).
Dimension Clinical Chemistry System
Assay: Ammonia AMM
Catalogue No: DF119
SMN: 10711991
Lots: FB7152 (Exp 1/6/17), EB7180 (Exp 29/6/17), BA7194 (Exp 13/7/17), EA7223 (Exp 11/8/17), BA7250 (Exp 7/9/17)
Dimension Vista System
Assay: Ammonia AMM
Catalogue No: K3119
SMN: 10711992
Lots: 16187BE (Exp 5/7/17), 16225BB (Exp 12/8/17), 16265AB (Exp 21/9/17)
ARTG Number: 181689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has determined that some lots of Ammonia (AMM) reagent used on both the Dimension® and Dimension Vista® Systems do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay message. These lots may exhibit accuracy shifts for patient and/or Quality Control results; which may cause laboratories to recalibrate more frequently than the of 60-day claim in the Instructions for Use (IFU). |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising customers to discard affected lots and to use alternate lots instead. Customers are also to check the acceptability of the calibration and QC.
This action has been closed out on 26/09/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |