Recall archive / FDA device enforcement
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels — FDA record Z-0958-2023
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 24, 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 Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
- Reason
- Reaction vessels may contain a potential contaminant that could affect their optical performance.
- Classification
- Class III
- Recalling firm
- Abbott Laboratories
- Quantity
- 70 cases
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0958-2023
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 | UDI-DI/Lots: 00380740129026/000586790 and 000586879 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
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
- Jan 25, 2023
- Recall initiation date
- Nov 24, 2022
- Center classification date
- Jan 17, 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.