Alinity M System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Alinity M System |
All lots. |
08N53-002 |
Issue
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
Additional information
Details
Abbott Molecular Inc.
1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018