CLASS II Device recall · Reported 24 Aug 2022 · FDA Enforcement Report
The Alinity m System recalled by Abbott Molecular
Abbott Molecular is recalling The Alinity m System. The recall was initiated on 19 Jul 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-1518-2022
- FDA event ID
- 90651
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 19 Jul 2022
- FDA classified
- 12 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Jul 2022 | Recall initiated by company | |
| 12 Aug 2022 | Classified by FDA | +24 days |
| 24 Aug 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect optical calibration
Product as listed by the FDA
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Where it was distributed
There was only foreign distribution to Italy.
Questions about this recall
Is The Alinity m System recalled?
Yes. Abbott Molecular recalled The Alinity m System on 19 Jul 2022. The recall is Class II and its status is Completed. Recall number Z-1518-2022.
Why was it recalled?
Incorrect optical calibration
Which lots are affected?
Serial Number 00654
Where was it sold?
There was only foreign distribution to Italy.
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.
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