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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
Model Number: 08N53-002
Products Sold
Model Number: 08N53-002
Abbott Molecular, Inc. is recalling Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing due to The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which ha. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 calibration may potentially have been configured.
Recommended Action
Per FDA guidance
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 Alinity m System(s). In the interim, please continue to follow your laboratory protocols for any suspected incorrect results. Following the assessment and any necessary service, an additional communication will follow. If it is determined that your instrument was impacted, please assess the impact to your laboratory in reviewing previously generated test results. This recall is to be carried out at the user/customer level. If this product has been further distributed by your facility, please notify any additional impacted customers. Please review this information with laboratory personnel and retain this communication for future reference. If you have any questions regarding the communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-553-7042 Option 2."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026