CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
Alinity m Integrated Reaction Units (IRU) recalled by Abbott Molecular
Abbott Molecular is recalling Alinity m Integrated Reaction Units (IRU), distributed nationwide in the US. The recall was initiated on 11 Feb 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-0710-2022
- FDA event ID
- 89603
- Recalling firm
- Abbott Molecular, Des Plaines, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Feb 2022
- FDA classified
- 2 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Feb 2022 | Recall initiated by company | |
| 2 Mar 2022 | Classified by FDA | +19 days |
| 9 Mar 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Product as listed by the FDA
Alinity m Integrated Reaction Units (IRU)
Where it was distributed
US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
Nationwide ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisKentuckyLouisianaMassachusettsMichiganMissouriNorth CarolinaNew JerseyNew YorkOklahomaRhode IslandSouth DakotaTexas
Questions about this recall
Why was it recalled?
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Which lots are affected?
List Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010 3) 771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010 4) 771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010 5) 773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010
Where was it sold?
US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
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.
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