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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00069-1
Product Name/Description	Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An in vitro diagnostic medical device (IVD) Multiple antibody and probes affected Product Codes: PA0552,PA0210,PB0614,PB0589,PB0645,PB0669,PB0809,PB0785 All lot numbers affected Affected Bond Polymer Refine Detection Kits Product Code: DS9800 Lot Numbers: 42314,42388,42474,42486,42499,42555,42570,42579,42627,42645,42683,42780,42802,42823,42852,43050 Expiry Dates: 02 April 2017 to 21 May 2017
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/01/2016
Responsible Entity	Leica Microsystems Pty Ltd
Reason/Issue	Leica Biosystems recently became aware that the product / detection kit combinations identified may not provide adequate staining when used according to the Instructions for Use. If the products are used according to their Instructions for Use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. The absence of adequate staining of tissue is likely to result in a delay in obtaining the results of IHC / ISH staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
Recall Action	Recall
Recall Action Instructions	Leica Biosystems is advising users to discontinue use of the listed antibodies / probes with the specified detection kits. There are alternative kits available for use. Leica is advising that there is no requirement for a review of previously reported results if appropriate positive controls were used.
Contact Information	03 9211 7402 - Leica Biosystems