Recall Z-1009-2023 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular, Inc.
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
| Date | Jan 20, 2023 (initiated Dec 9, 2022) |
| Status | Open, Classified |
| Reason | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (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 |
| Root cause | Under Investigation by firm |
| Action | On December 09, 2022, Abbott Molecular issued a Field Correction Recall/Urgent Field Safety Notice to all customers who have the Alinity m System by FedEx priority overnight express. The letter explained the problems and provided the following information: "An assessment of your Alinity m System associated with the above listed potential issues will be completed remotely if your system is currently connected to AbbottLink or alternatively via onsite inspection by an Abbott representative. If necessary, an Abbott representative will schedule time to corrected the affected ADU9s) on your Ali |
| Quantity | 918 units |
| Distribution | x |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.