Recall archive / FDA device enforcement
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 — FDA record Z-0739-2023
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 22, 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 Resp-4-Plex Amp Kit, Part Number 09N79-096
- Reason
- Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- Classification
- Class II
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 3896 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0739-2023
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 | Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 28, 2022
- Recall initiation date
- Nov 22, 2022
- Center classification date
- Dec 20, 2022
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.