ALPHA-METHYLACYL-COA RACEMASE (AMACR P504S) and BONDS READY-TO-USE… — recall 54827
Health Canada — Medical Devices · Canada · 2016-01-22 · Type II
As described by Health Canada — Medical Devices: ALPHA-METHYLACYL-COA RACEMASE (AMACR P504S) and BONDS READY-TO-USE (2015-12-15)
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Archived by the issuing authority — kept for reference
Reported risk: These antibodies and probes, when used in combination with specified lots of the Bond Polymer Refine Detection and Novolink Polymer Detection System, 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.
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