Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid te...
FDA Recall #Z-1009-2023 — Class II — December 9, 2022
Product Description
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.
Reason for Recall
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.
Recalling Firm
Abbott Molecular, Inc. — Des Plaines, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
918 units
Distribution
x
Code Information
Model Number: 08N53-002
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.