| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00155-1 |
| Product Name/Description |
Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)
Lot Number: 09045
Expiry Date: 16 October 2014
Kit Reference Number: CDB80991 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Thermo Fisher Scientific would like to inform that the use of Calibrator BRAHMS Free beta-hCG KRYPTOR CAL may result in a decreased Free beta-hCG concentration for BRAHMS GM KRYPTOR QC as well as for patient samples by approximately 4%. This may lead to incorrect risk estimation of chromosomal anomaly of the foetus. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher Scientific is advising users to stop use of the affected lot number. The affected lot will be replaces by a previous calibrator which may have a shorter expiry date. Thermo Fisher is recommending that results generated with the affected calibrator are re-evaluated in the context of other laboratory and clinical parameters and retest if required. |
| Contact Information |
02 8817 4108 - Thermo Fisher Scientfic |