Panocell-20 and Capture-R Ready-ID. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00305-1

Class III

2017-03-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00305-1

The manufacturer, immucor has identified issues with panocell-20 and capture-r ready-id.For panocell-20, donor e1011 was listed as v+ (positive) on the master list supplied with this product. the donor has subsequently been tested as v - (negative). since donor e1011 is v–, cell number 11 will be nonreactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system. for capture-r ready-id, donor d1741 was listed as v+ (positive) on the master list supplied with this product. dna testing of this donor has confirmed the donor as v - (negative). since donor d1741 is v–, cell number 4 will be non-reactive with specimens that may contain anti-v. v (rh10) is a low prevalence antigen in the rh system.

Seqirus is providing revised master lists for the affected products which correctly identify the donors as V- (negative). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 05/07/2017.