Abbott has identified three potential issues which may have impacted the amplification detection unit(s) (ADU) installed on your Alinity M system. 1. systems which had their ADU's serviced may have an incorrect boardvalue (calibration data file) referenced causing a misconfiguration of the calibration. 2. inability of maintenance and diagnostics 2300 (amp detect optical calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. under specific conditions during the adu manufacturing process, an incorrect calibration may potentially have been configured. Recall start date: December 13, 2022
RecallTracker