Medical device manufacturer, Bio-Rad, has issued a safety alert concerning its DiaMed Q.C. System. The affected devices are identified as the following:-
The manufacturer has been made aware that samples of the product DiaMed Q.C. System, IHD lot number 45950 46 1 and 45950 47 1, show excessive hemolysis in samples 1 and 4, and weakly in sample 2.
Tests have been performed internally and the manufacturer can confirm that currently a clear result is returned with manual testing and on the Saxo- Swing, IH-1000 with the hemolysed QC samples. With IH-500, users may observe uninterpretable results on reverse grouping. In this case, users should use another sample to perform the reverse grouping. [Note: tests involving serum 1 and serum 2 are in no way affected.]
According to the manufacturer, a risk assessment has been performed and no patient risk has been identified. Users may continue to use the hemolysed cells as long as they give the expected results.
The current Situation has shown that the hemolysed lots will still allow the customers to perform QC testing for the following applications:
According to the local supplier, the affected products are not distributed in Hong Kong
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 September 2017