| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01174-1 |
| Product Name/Description |
BFT II Analyser
(Coagulation studies analyser)
Catalogue Number: OVKF03
Siemens Material Number: SMN 10458677
ARTG Number: 178116
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Standard Human Plasma (SHP, REF ORKL) pre-dilution ratios given in the Reference Guides of the BFT II Analyser do not correspond to the standard dilution procedure for endogenous coagulation factor determination. The incorrect dilution ratio stated in the Reference Guides is limited to the lowest calibration point. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens are advising their customers to discontinue use of the affected application sheet for the calculation of endogenous coagulation factors from the BFT II Reference Guide Versions 3.00, 3.01 and 3.02. A revised Reference Guide will be provided. A look back at previous results is not recommended however this requirement should be determined at the discretion of the laboratory. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |