Roche Diagnostics Ltd

In addition to the Field Safety Notice which details affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information.Product name Expanded Affected Lots Previously Communicated Lots OptiView DAB IHC Detection Kit Y24225, Y25760, E00119 Y19271, Y11625, Y15571 ULTRAVIEW UNIVERSAL DAB DETECTION KIT Y22147, Y25695 Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069 iView DAB Detection Kit Y24245 Y11834 ultraView SISH Detection Kit None Y15133 OptiView Amplification Kit None Y15435, Y19322, Y22447 OptiView Amplification Kit (250 Test) Y26282 Y19318 ultraView SISH DNP Detection Kit Y26299 Y17990 Hematoxylin II None Y10759, Y13938, Y17402, Y17403, Y21312 ISH iVIEW Blue Plus Detection Kit Y15410, Y24365 N/A ANTI-PAN KERATIN Primary Antibody, 25mL Y21610 N/A ultraView Universal Alkaline Phosphatase Red Detection Kit Y15071, Y18053, Y22469 N/A ISH Protease 3 Y13927, Y18872, Y22569, Y25883 N/A CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody Y12992, Y18852, Y23051 N/A CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody Y18586, Y24472 N/A VENTANA ISH iView Blue Detection Kit Y15105, Y22455 N/A INFORM HPV III Family 16 Probe (B) Y19417 N/A VENTANA anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody Y24119 N/A CINtec p16 Histology (250) CE Y16507, Y23040 N/A