DiaMed Q.C. System. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01183-1

Class II

2017-09-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01183-1

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.

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.