FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: Alinity m Integrated Reaction Units (IRU)
- Recall number
- Z-0710-2022
- Recalling firm
- Abbott Molecular, Inc.
- Product
- Alinity m Integrated Reaction Units (IRU)
- Status
- Terminated
- Initiated
- 2022-02-11
- Posted
- not on file
- Terminated
- 2023-04-14
- Reason
- There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 3063 kits
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OOI
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28