| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00106-1 |
| Product Name/Description |
Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
Catalogue Number: K1023
Siemens Material Number: 10445160
Lot Number: 17171BD
ARTG Number:181686
(Siemens Healthcare Pty Ltd - Clinical chemistry electrolyte IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that the affected Dimension Vista Calcium (CA) Flex reagent cartridge may produce erroneously low results from specific well sets.
Quality Control (QC) may not detect the issue prior to patient testing if the CA calibration and QC are both processed in either an affected or unaffected well set.
If CA reagent calibration is performed using an unaffected well set and QC and samples are subsequently processed using an affected well set, CA results may be falsely depressed, with observed biases from -0.075 mmol/L] to -0.7 mmol/L.
If a CA reagent calibration is performed using an affected well set, and QC and patient samples are subsequently processed using an unaffected well set, CA results may be falsely elevated.
The observed bias for serum, plasma, and urine specimens are similar. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens Healthcare is advising users to discontinue use of, and discard the Dimension Vista Calcium Flex reagent lot 17171BD.
This action has been closed out on the 11/12/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |