| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01183-1 |
| Product Name/Description |
DiaMed Q.C. System. An in vitro diagnostic medical device (IVD)
Material Number: 45950
Lot Number IHD: 45950 46 1
Lot Number SAP: 166035461
Expiry: 25/09/2017
Lot Number IHD: 45950 47 1
Lot Number SAP: 172383471
Expiry: 09/10/2017
ARTG Number: 232955 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad Laboratories have been made aware that samples of the product DiaMed Q.C. System, (IHD lot 45950 46 1 and 45950 47 1) show excessive haemolysis in samples 1 and 4 and weakly in sample 2.
Haemolysed cells may continue to be used as long as they give the expected results. Internal tests performed by Bio-Rad have confirmed that a clear result is returned with manual testing and on the Saxo-Swing, IH-1000 with the haemolysed QC samples. With IH-500 you may observe uninterpretable results on reverse grouping. In this case, please use another sample to perform the reverse grouping. Note: tests involving serum 1 and serum 2 are in no way affected.
The current situation has shown that the haemolysed lots will still allow the customers to perform QC testing for the following applications:
- Typing ABO/D and phenotype Rh Kell
- Antibody screening and identification
- Compatibility testing |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Distribute this information with in your facility to all those who need to be aware of this notice
2. Bio-Rad kindly requests you to discard all remaining kits of these affected lots, once replacements have been received. Bio-Rad will provide a replacement once the supplied response form is received..
3. Complete and return the supplied customer response form to Bio-Rad Laboratories as acknowledgment of receipt of this important information, even in the absence of stock.
4. If you have forwarded any product within your facility, please provide a copy of this letter to them and advise Bio-Rad Laboratories.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 224 354 Bio-Rad Laboratories |