Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01362-1
Product Name/Description	Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD). 50 Test kit Batch Number:- C323026 Product Code IM77 100 Test kit Batch Number:- C323027 Product Code IM771
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	24/12/2014
Responsible Entity	Immuno Pty Ltd
Reason/Issue	Specific product codes for the Anti-dsDNA Kit (used to test for antibodies to dsDNA), were omitted in error from the packaging material. Customers have received the correct products, however due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (IM77 lot C323026) or 100 tests version (IM771 lot C323027). The kits can be differentiated by the lot numbers printed on the outer box. Please note that the individual component labelling within the kit has not been affected. The Tracer and Ammonium Sulphate Solution lot numbers were omitted for these particular lots of product listed above.
Recall Action	Recall for Product Correction
Recall Action Instructions	A set of labels (stickers) will be provided to customers to place over the existing directions that will correct the problem. The Customer Letter contains detailed instructions on where to place the stickers – including examples in the form of pictures. This action has been closed-out on 02/03/2016.
Contact Information	1800 252 215 - Immuno Pty Ltd