| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01056-1 |
| Product Name/Description |
ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)
Test code: Cal U
Catalogue Number: 03684480
Siemens Material Number: 10309996
Kit Lots ending in 63 (Expiry 03 Oct 2016) and 64 (Expiry 17 Jan 2017)
ARTG Number: 175075 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that the ADVIA Centaur Systems Myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/mL (ug/L) as specified in the ADVIA Centaur Myoglobin Instructions for Use (IFU), for all in-date reagent lots when evaluated with Calibrator U kit lots ending in 63 and 64. Values up to 12 ng/mL (ug/L) were observed.
Siemens’ investigation has identified that certain Calibrator U kit lots have drifted from the internal standardisation causing a positive shift in results.
Analytical sensitivity and alignment to the internal standardisation will be restored with the release of Calibrator U kit lots ending in 65 (CU65) and higher.
Customers will observe a negative shift in Quality Control (QC) material and patient results when transitioning to CU65. As a result, revised QC targets and ranges for Bio-Rad controls have been established and published on the Bio-Rad website at QCnet.com. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising that customers may continue to use Calibrator U lots CU63 and CU64 with any in-date reagent kit lot and current QC ranges. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher.
Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the laboratory.
Update 7 October 2016: Siemens are advising that Calibrator kit lot CU65 is now avaliable. The use of lots CU63 and CU63 should be discontinued and the lots discarded.
This action has been closed out on 07/11/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |