| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00807-1 |
| Product Name/Description |
Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)
Catalogue Number: DF33B
Siemens Material Number: 10872079
All lot numbers affected
ARTG Number: 181689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified that Dimension Creatinine (CRE2) Assay exhibits a negative bias at the low end of the urine Analytical Measurement Range (AMR). The Limit of Quantitation (LoQ) claim 442 µmol/L for urine samples is not met. This issue affects all future lots of CRE2 until a solution is implemented. The serum/plasma CRE2 AMR is not affected by this issue.
The bias observed for urine creatinine samples < 1149 ìmol/L would not impact clinical interpretation of adult eGFR calculations or clinical interpretation of laboratory tests utilising creatinine as a correction factor, such as Urine Albumin/Creatinine ratio and/or Urine Protein/Creatinine ratio. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to review the maximum observed bias for low urine concentrations. It is recommended that urine CRE2 values that are less than 1149umol/L are reported as <1149umol/L rather than an actual numeric results. Siemens is providing work around instructions for users to change the lower assay range parameters to 1149umol/L. Siemens is not recommending a review of previously generated results, however a review is at the discretion of the laboratory.
This action has been closed out on 28/09/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |