Randox Liquid Cardiac Controls when used with CKMB and Myoglobin assays. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00632-1

Class II

2017-05-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00632-1

Randox has confirmed a change in recovery with regards to ckmb in lot 3912ck (expiry 28 october 2017) of the liquid cardiac control 3. a similar issue with myoglobin has previously been reported for this lot (recall for product correction, notice 284 dated 17th feb 2017, tga ref. rc-2017-rn-00340-1). all other analytes recover as expected. taking into consideration the other related previously issued recall for product correction (notice 284) for the liquid cardiac controls 1, 2 & 3, the ifu for each of these controls has been updated to indicate in the storage and stability section that values for ckmb and myoglobin may gradually decrease over the product shelf-life for the liquid cardiac controls. this limitation applies to specific lots that have been supplied and to all future lots of liquid cardiac controls. if the control material is affected it is apparent immediately as the value will not fall within the assigned range.

Randox is providing users with a notice and revised IFU template that states that CKMB and Myoglobin values in CQ5051, CQ5052 and CQ5053 may gradually decrease over the shelf life of the products. Users are to place the notice and revised IFU in the kit of all affected Liquid Cardiac Control products.