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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00921-1
Product Name/Description	illumigene Malaria Kit. An in vitro diagnostic medical device (IVD). Catalogue Number: 280925 Kit Lot Numbers: 280925H009 Expiry: 23 August 2017 Component involved: 2824.005 280925H010 Expiry: 23 August 2017 Component involved: 2824.006 280925J011 Expiry: 24 July 2018 Component involved: 2824.008 280925J013 Expiry: 24 July 2018 Component involved: 2824.009 280925J015 Expiry: 19 June 2018 Component involved: 2824.007 ARTG Number: 277788
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	8/08/2017
Responsible Entity	Bioline Aust Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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. This action has been closed out on 17/10/2018
Contact Information	02 9209 4180 - Bioline Australia