HER2 CISH PHARMDX KIT

Description of Event or Problem

WEAK AND HETEROGENEOUS RED SIGNALS HAVE BEEN OBSERVED IN SPECIFIC LOTS OF HER2 CISH PHARMDX KIT AND REPORTED BY EX-US CUSTOMERS AND INTERNAL DAKO CUSTOMER. REDUCED ACTIVITY OF ONE BATCH OF THE ENZYME-ANTIBODY CONJUGATE WAS IDENTIFIED AS THE ROOT CAUSE OF WEAK RED SIGNALS, AND THIS SPECIFIC BATCH WAS USED IN THE CISH ANTIBODY MIX (VIAL 8) OF HER2 CISH PHARMDX KIT, CODE SK109 LOT NUMBER 00092789 AND 20002057 NOT DISTRIBUTED IN THE USA AND LOT 20000910, DISTRIBUTED IN THE U.S.. THERE ARE NO COMPLAINTS OF WEAK STAINING HAVE BEEN SUBMITTED ON LOT 2000090. WITH CORRECT USER CONTROL VERY LOW RISK IS ASSOCIATED WITH THIS PRODUCT. INCORRECT OR ABSENT QUALITY CONTROL BY THE USER PRIOR TO ENUMERATION OF STAINED SLIDES WILL TRIGGER THE RISK. ACCORDING TO INSTRUCTIONS FOR USE RED AND BLUE SIGNALS NEED TO BE CLEAR, WELL BALANCED IN INTENSITY, DISTINCT AND EASY TO EVALUATE ON THE STAINED SLIDE PRIOR TO ENUMERATION OF RED AND BLUE SIGNALS. NO EVIDENCE THAT PATIENTS WERE MISDIAGNOSED. IF ENUMERATION IS DONE IN SITUATIONS WHERE QUALITY CONTROL WAS NOT FOLLOWED, FEWER RED SIGNALS MAY BE FOUND. A REDUCED NUMBER OF RED SIGNALS LEAD TO A REDUCED HER2/CEN-17 SIGNAL RATIO, AND WEAKLY AMPLIFIED CASES MAY BE FALSELY INTERPRETED AS NON-AMPLIFIED BY THIS ERROR.

Additional Manufacturer Narrative

HER2 CISH PHARMDX KIT IS INTENDED FOR DUAL-COLOR CHROMOGENIC VISUALIZATION OF SIGNALS ACHIEVED WITH DIRECTLY LABELED IN SITU HYBRIDIZATION PROBES TARGETING THE HER2 GENE AND CENTROMERIC REGION OF CHROMOSOME 17. THE KIT IS DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE STATUS IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. RED AND BLUE CHROMOGENIC SIGNALS ARE GENERATED ON THE SAME TISSUE SECTION FOR EVALUATION UNDER BRIGHT FIELD MICROSCOPY. THE CISH PROCEDURE IS AUTOMATED USING DAKO AUTOSTAINER INSTRUMENTS. HER2 CISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.