[45761314]
The production team responsible for this product discovered that, due to human error, the wrong titration method was used when producing the probe mix (po1779) for two lots of the product. These lots were released to the market prior to discovery of the error. The error resulted in the dna probe concentration being approximately 4 to 5 times lower than usual for this product. The affected lots of sk109 met final qc acceptance criteria for cish staining performance. However, the lower dna probe concentration could reduce the stability of the dna probe mix and/or reduce the robustness of the staining performance in relation to pre-analytical factors such as tissue fixation and preparation. The error was discovered by the production team on 28-apr-2016. Only one of the lots has been distributed in the us, this is lot 20031683. The other affected lot 20031665 and not been sold in the us but only in the rest of the world. No incidents have been reported by customers, and the likelihood of indirect harm to a patient due to re-biopsy is considered "very unlikely" because (a) the majority of ffpe tissue specimens collected for diagnostic purposes contain sufficient tissue for several separate staining's (i. E. , retests), and (b) the majority of re-biopsy procedures do not lead to serious medical complications. There is no risk of incorrect diagnosis due to false negative or false positive test results. If sk109 is used according to the ifu then normal cells within the tumor tissue section would serve as internal controls for assay failure, and assay failure would have a very high probability of being detected because the expected signals for her2 and cen-17 would not be present in both normal and tumor cells in the tissue sample.
Patient Sequence No: 1, Text Type: D, B5