Alinity m recallZ-0710-2022 · Abbott Molecular, Inc. · initiated Feb 11, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Molecular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
FDA root cause category: Under Investigation by firm
What the company is doing
On February 11, 2022, Abbott Molecular issued a Product Recall letter to all customers who received Integrated Reaction Unit (IRU) List Number 09N26-010 Lot Numbers 766233, 770433, 771200, 771201, and 773642 used with the Alinity m System. Consignees must complete and return the included customer reply form. Customers are instructed to follow the Necessary Actions outlined in the Customer Letter: Discontinue use of and discard all remaining inventory of IRU Lots 766233, 770433, 771200, 771201, and 773642. To coordinate replacement, contact your local Molecular Diagnostics at Abbott representative. If RVs are found inside the instrument with no cap and there are associated 1998 errors, please contact an Abbott representative to inspect the instrument. Results generated between the onset of the associated 1998 errors and the identification of the RV with no cap inside the instrument should be considered presumptive. Retesting of samples that yielded positive results during this timeframe should be considered.
Recall details
- Recall number
- Z-0710-2022
- Status
- Terminated
- Initiated by the company
- Feb 11, 2022
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 3063 kits
- Product code
- OOI
- Distribution
- 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.
Product description
Alinity m Integrated Reaction Units (IRU)
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity m 09N26-010Abbott Molecular Inc. · real time Nucleic acid amplification system1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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