Recall Z-1009-2023— Abbott Molecular, Inc.

Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-12-09. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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 calibration may potentially have been configured..

Recalling firm

Abbott Molecular, Inc.

Classification

Class II

Status

Ongoing

Initiated

2022-12-09

Firm location

Des Plaines, IL, United States

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