DuraClone B27 Reagent Kit - an in vitro medical device 의 리콜

Recall

RC-2017-RN-01514-1

Class II

2017-12-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01514-1

As a result of internal investigations, beckman coulter has determined that certain duraclone b27 reagent kits have a defect that may generate false negative results in some samples. this defect is most likely to affect samples with mfi values between 10 to 19 when tested on navios/cytomics fc 500 cytometers and channel values between 517 to 602 when tested on bd facscalibur/ bc facscan cytometers.There has been no report of death or injury related to this defect.

Beckman Coulter is advising users to run tests of lot numbers 050917, 070417_11, 090517, 120617_02, 170417_09, 170417_11, 170417_11, 190617 and 240717 with the new determinant and indeterminant zone values provided with the Customer Letter. Other affected lot numbers should be disposed of in an appropriate manner. Affected customers may contact their local Beckman Coulter representative for replacement product. Beckman Coulter recommends if required, redetermination of those results obtained for the above specified 8 lot numbers using the new determinant values outlined in the Customer Letter. For all lot numbers, Beckman Coulter recommend samples previously reported as ‘negative’ to be verified using alternate methods such as PCR if considered necessary.