Corrective Action for Globalfiler® data collection by ABI 3500 Genetic Analyzer Instrument:
On or around January 31, 2022, it was brought to SERI’s attention that certain Globalfiler® re-injections ran on the 3500 were not being performed at the validated 1.2 kilovolt (hereinafter kV) injection. Under certain and limited circumstances, re-injections were performed at 3 kV rather than the validated 1.2 kV. The re-injection protocols were corrected from 3kV to 1.2kV on February 2, 2022. The date range of cases affected is January 2017 to January 2022. The investigation confirmed there was no defect in the 3500 instrument, no defect in the data collection software, and no defect in the Globalfiler® amplification kit. All agencies affected by the 3kV injection have been notified, and where necessary, amended reports have been issued.