CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Abbott Alinity m Resp-4-Plex Amp Kit recalled by Abbott Molecular
Abbott Molecular is recalling Abbott Alinity m Resp-4-Plex Amp Kit. The recall was initiated on 22 Nov 2022 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-0739-2023
- FDA event ID
- 91202
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2022
- FDA classified
- 20 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2022 | Recall initiated by company | |
| 20 Dec 2022 | Classified by FDA | +28 days |
| 28 Dec 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Product as listed by the FDA
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Where it was distributed
Worldwide
Questions about this recall
Is Abbott Alinity m Resp-4-Plex Amp Kit recalled?
Yes. Abbott Molecular recalled Abbott Alinity m Resp-4-Plex Amp Kit on 22 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0739-2023.
Why was it recalled?
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Which lots are affected?
Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499
Where was it sold?
Worldwide
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled | Abbott Molecular | Other | Nationwide |
| Device | CLASS II | The Alinity m System is designed to automate the steps recalled | Abbott Molecular | Other | Nationwide |
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