Abbott Alinity m System Nucleic Acid Testing Device Calibration Recall
Abbott Molecular is recalling 918 Alinity m nucleic acid testing systems due to three identified potential calibration and configuration errors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a medical diagnostic device with potential calibration errors. The identified issues represent configuration risks without confirmed equipment failures, placing this at Severity 3 (High) per the rubric's criteria for risk-of-harm products.
Plain-English summary
Abbott Molecular, Inc. is recalling 918 units of the Alinity m System (Model 08N53-002), which is designed to automate nucleic acid testing procedures.
The firm identified three potential issues affecting the Amplification Detection Units (ADUs) in distributed systems. First, serviced ADUs may reference an incorrect calibration data file, resulting in misconfiguration. Second, the Maintenance and Diagnostics 2300 system may fail to recognize certain errors during calibration, potentially causing misconfiguration. Third, specific conditions during ADU manufacturing may have resulted in incorrect calibration.
The FDA classified this as a Class II recall (Z-1009-2023).
The recalled product
- 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
- Abbott Molecular, Inc.
- Hazard
- calibration-error
- configuration-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 08N53-002
Distribution
Distribution scope not specified by the agency.
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