illumigene Malaria Kit. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00921-1

Class III

2017-08-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00921-1

The manufacturer meridian has discovered that the sample preparation apparatus iv is susceptible to evaporation over the shelf life, causing low volume of the liquid reagent. post-market studies indicate that this component may not be stable through to the labelled expiration date due to this evaporation. internal testing by meridian has confirmed that the use of a low volume sample preparation apparatus component will result in an invalid test result.At this time, there is no indication that valid test results are impacted, and previously reported patient results require no additional action.

Meridian is requesting customers: 1. Identify existing inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015; 2. Contact Bioline directly, as necessary, for replacement product; 3. Complete and return the supplied Customer Response Form to Bioline; and 4. Upon receipt of replacement product, segregate and destroy remaining inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015. All kit components should be discarded in accordance with local regulations.