CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report
Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled
Abbott Molecular is recalling Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse, distributed nationwide in the US. The recall was initiated on 28 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1749-2025
- FDA event ID
- 96790
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Apr 2025
- FDA classified
- 12 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 28 Apr 2025 | Recall initiated by company | |
| 12 May 2025 | Classified by FDA | +14 days |
| 21 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There were reports of an increase in reactive negative controls and false positive results.
Product as listed by the FDA
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
There were reports of an increase in reactive negative controls and false positive results.
Which lots are affected?
UDI-DI: 00884929049390; Lot Number: 409384
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96790| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled | Abbott Molecular | Other | Nationwide |
More recalls from Abbott Molecular
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled | Abbott Molecular | Other | Nationwide |
| Device | CLASS II | The Alinity m System is designed to automate the steps recalled | Abbott Molecular | Other | Nationwide |
| Device | CLASS II | Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled | Abbott Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled | Abbott Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | Alinity m System recalled by Abbott Molecular | Abbott Molecular | Other | Nationwide |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |