ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00373-1

Class II

2016-04-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00373-1

It has been confirmed that in specific conditions, the anti-n (mns2) of certain lots of cards id-diaclon anti-n (ref. 007111) and id-diaclon anti-m/n (ref. 006011) may give an unexpected interference with n negative samples.Investigations have identified that this phenomenon is temperature dependent, becoming stronger if the ambient temperature drops to the lower range of room temperature, 18-25°c and tending to disappear once the temperature reaches the upper limit of this range. reagents and samples that are at the lower end of the room temperature range will also increase the interference.The reported issue may result in false positive results which can lead to a delay in transfusion decisions.

Bio-Rad is advising users NOT to validate a positive result that gives reaction strength lower than 3. The automatic validation function on the instruments should be disabled when carrying out tests MO45D and PR44N. Bio-Rad will provide manual test kits to confirm the results obtained for negative 1+ and 2+ reactions when requested. The sponsor is working on a permanent solution and the users will be notified once unaffected products become available. This action has been closed-out on 09/05/2017.