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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 918
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.
Related recalls
Same manufacturer · Abbott Molecular, Inc.
See all →- HighAbbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall
FDA (Devices) · 2025-05-21
- HighAbbott Alinity m Resp-4-Plex Amplification Kit Recall
FDA (Devices) · 2025-05-21
- ModerateAlinity m System nucleic acid testing instruments recalled for liquid spillage
FDA (Devices) · 2025-04-30
- HighAbbott Alinity m HPV test kit control failures from iron contamination
FDA (Devices) · 2024-11-06
- HighAbbott STI and HPV Test Kits Recalled for Quality Control Failures
FDA (Devices) · 2024-11-06
Same hazard · calibration error
See all →- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
Similar recalls
- ModerateAlinity m System nucleic acid testing instruments recalled for liquid spillage
FDA (Devices) · 2025-04-30
- HighAbbott Alinity m System Recall: Missing Components and Improper Calibration
FDA (Devices) · 2023-04-12
- HighAbbott Alinity m System Molecular Diagnostic Device Amplification Defect Recall
FDA (Devices) · 2022-01-12
- HighAlinity m System recalled for software defect in amplification detection
FDA (Devices) · 2022-01-12
- HighDiagnostic System Software Defects Affecting Sample Processing and Test Accuracy
FDA (Devices) · 2022-11-30
- HighAbbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration
FDA (Devices) · 2022-08-24