Medical device manufacturer, Abbott Laboratories Ltd, has issued a field safety notice concerning m2000sp instrument, with affected list number 09K14. All assays run on the m2000sp instrument that require manual entry of calibrator and control expiration dates, lot numbers, and calibrator and control concentration values were affected.
According to the manufacturer, there was an issue on the m2000sp Instrument software when information is entered incorrectly during the creation of a Sample Extraction Test Order. An issue may occur only when the correction is made to manually entered calibrator or control information after the operator have progressed beyond the "Sample Extraction: Sample Scan" Screen and the operator do not re-scan the sample tubes and racks after data correction on the "Sample Extraction: Assay Detail" screen. An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved. This software issue will occur if some specific steps are followed.
Furthermore, the manufacturer advises users that when entering calibrator or control information on the Sample Extraction: Assay Details Screen, verify that the information is correct prior to proceeding to tile next screen. If identifying that the entered information is incorrect, users can correct the information by following options or steps suggested by the manufacturer. The manufacturer will deploy a new corrective software upgrade by the end of first quarter 2013.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 17 December 2012