Recall archive / FDA device enforcement
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. — FDA record Z-1349-2023
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 Nov 11, 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
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- Reason
- The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
- Classification
- Class II
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 1
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1349-2023
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 | Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to state of: PA, a government account.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 12, 2023
- Recall initiation date
- Nov 11, 2022
- Center classification date
- Apr 6, 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.