Ready-Prep %CDT by HPLC using the CDM software version MVC133091. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01532-1

Class III

2017-12-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01532-1

Bio-rad have observed that the lot numbers for mobile phase 2 [mp][2] and mobile phase 3 [mp][3] on the cd-rom cover print and within the method for the cdm software are not correct for the affetced cd-rom, due to a defect in the manufacturing process of the cd-rom.Thus, the printed numbers on the cd-rom do not correspond to the correct lot numbers of mobile phase 2 and mobile phase 3 which were delivered with the associated kits.The wrong lot numbers within the cdm method will affect only customers using the cdm software: the wrong lot numbers within the method of the cdm software will result in transfer of the wrong lot numbers into the users cdm software, and false lot numbers printed in the summary reports of the analytical runs. this may result in difficulties of the traceability of used mobile phases. due to the fact that the wrong lot numbers are not used for any other reagents or components of any %cdt by hplc test there is no risk of false traceability.

Bio-Rad is advising users to immediately check the documentation obtained by using the CD-ROM of the affected lots. If users have used the CD-ROM to read in the lot numbers into the CDM software, correct the MP2 and 3 lot numbers in the CDM software manually (as described in the CDM manual Version 4.0, chapter 5.1.4). Alternatively, discontinue use of the CD-ROM and Bio-Rad will replace the CD-ROM when the quality issue is resolved.