API ZYM B. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-01270-1

Class II

2015-12-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01270-1

Based on discrepant results (false negative results) reported from the field, biomérieux initiated a complaint investigation to confirm product performance and determine root cause. the investigation confirmed a loss of performance after 3 months of shelf life for api zym b, which led to false negative results on some api strips using the zym b reagent. as a result of the zym b performance shift, the risk is to potentially report a false negative result of some api tests; misidentification of some species with api 20 strep, api nh, api listeria and api coryne. api staph is not impacted by a risk of misidentification. regarding api zym, as it is designed for the research of enzymatic activities, there is no risk of microorganism misidentification.

Biomerieux is advising users to perform quality control with ATCC strains prior to using the ZYM B ampule. A review of previously reported results is recommended at the discretion of the Laboratory Director.