ULTRAVIEW UNIVERSAL ALKALINE PHOSPHATASE RED DETECTION KIT

Additional Manufacturer Narrative

DATA ANALYSIS REVEALED THAT THE ULTRAVIEW UNIVERSAL AP RED DETECTION KIT (05269814001), LOT N04707, WAS COMPLIANT WITH ALL QUALITY CRITERIA AT THE TIME OF RELEASE. REVIEW OF THE ELECTRONIC BATCH RECORD DID NOT INDICATE ANY NON-CONFORMANCES OR MANUFACTURING ISSUES THAT WOULD CONTRIBUTE TO THIS ISSUE. REVIEW OF THE ANTIBODY ASSAYS USED IN THE TESTING INDICATED THREE ROCHE/VENTANA ASSAYS: ANTI-MELANOSOME (HMB45), LOT N09753, CINTEC P-16 HISTOLOGY, LOT N06466, AND PRAME (EPR20330), LOT N16180. IT WAS NOTED THAT THE INCUBATION TIME FOR THE ANTI-MELANOSOME (HMB45), LOT N09753, ASSAY WAS 12 MINUTES IN THE CUSTOMER PROTOCOL BUT 8 MINUTES IN THE PRODUCT METHOD SHEET. THE PROTOCOL USED FOR PRAME (EPR20330), LOT N16180, WAS ALIGNED WITH THE METHOD SHEET. THE PROTOCOL USED FOR CINTEC P-16 HISTOLOGY INCLUDED 36 MINUTES OF ANTIBODY INCUBATION COMPARED TO 20 MINUTES RECOMMENDED IN THE METHOD SHEET. THE ASSAYS FOR KI-67 AND SOX10 WERE PERFORMED USING PREP-KITS, WHICH ARE USER-FILLED, THIRD-PARTY ANTIBODIES. THE ORDER OF THE SLIDES ON THE RUN WAS ALSO EVALUATED, BUT DID NOT INDICATE A CLEAR PATTERN OF STAINING, WHICH WOULD INDICATE DEGRADATION OR EMPTY WITH TEST REMAINING ISSUES. THE APPROPRIATE STAINING OCCURRING ON THE SAME INSTRUMENT WITH A NEW DETECTION KIT LIKEWISE RULES OUT AN INSTRUMENT ISSUE. DUE TO THE APPROPRIATE STAINING PRODUCED WITH THE SAME ANTIBODIES AND A NEW LOT OF ULTRAVIEW UNIVERSAL AP RED DETECTION KIT (05269814001), A POSSIBLE CAUSE FOR THE INCONSISTENT RESULTS IS A DISPENSER FAILURE IN THE ORIGINAL DETECTION KIT.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE STAINING RESULTS WITH THE ULTRAVIEW UNIVERSAL ALKALINE PHOSPHATASE RED DETECTION KIT USING THE BENCHMARK ULTRA INSTRUMENT. THE INITIAL TESTING OF A PATIENT BLOCK SHOWED FALSE-NEGATIVE RESULTS FOR SEVERAL MARKERS, ALTHOUGH THE CONTROLS WERE POSITIVE. A REPEAT STAINING WITH A DIFFERENT LOT OF THE SAME DETECTION KIT YIELDED THE EXPECTED POSITIVE RESULTS.