Recall archive / FDA device enforcement
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sam... — FDA record Z-1009-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 918 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1009-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: 08N53-002 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
x
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 1, 2023
- Recall initiation date
- Dec 9, 2022
- Center classification date
- Jan 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.