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Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes s

Recalled February 1, 2023 · FDA recall Z-1009-2023 · Abbott Molecular

Hazard
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. · FDA Class II
Units
918 units
Sold at
x

Description

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.

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.
Manufacturer(s)
Abbott Molecular, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes s | RecallWatchUSA