| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01374-1 |
| Product Name/Description |
Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD).
ADVIA Chemistry Calibrator
Siemens Material Number (SMN): 10312279
Lot Numbers: 680726 (exp. 2017-06), 680726A (exp. 2017-09), 680726B (exp. 2017-09), 680726C (exp. 2018-02), 680726D (exp. 2018-02)
ARTG Number: 185171 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed that for several lots the currently assigned DBIL_2 Assigned Calibrator Values (ACVs) may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement. Quality control (QC) material is also affected by this issue. Depending on the quality control concentrations and ranges used by the laboratory, quality control may not detect this issue.
The positive bias may lead to an overestimation of direct bilirubin and the potential for further monitoring or confirmation of a potentially abnormal direct bilirubin finding during the assessment of liver dysfunction and/or during the investigation of jaundice. To correct the positive bias and restore alignment to the reference method, the ACV for DBIL_2 has been reassigned from 77 micromol/L to 55 micromol/L. All other analytes present in the Chemistry Calibrator meet product standards. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to use the reassigned DBIL_2 ACVs for the affected Chemistry Calibrator lot numbers. In addition, laboratories should review the targets and ranges for quality controls used with the DBIL_2.
This action has been closed out on 24/10/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Solutions Centre |