Z-0710-2022Class II

Alinity m Integrated Reaction Units (IRU)

Name: Z-0710-2022 Alinity m Integrated Reaction Units (IRU)
Creator: Abbott Molecular, Inc.
Published: 2022-02-11
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-02-11 / Terminated

FDA source

Abbott Molecular, Inc. began a recall of Alinity m Integrated Reaction Units (IRU) on 2022-02-11. FDA classified it as Class II and gives the reason as "There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0710-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-11
Posted: 2022-03-02
Terminated: 2023-04-14
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m Integrated Reaction Units (IRU)
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0710-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0710-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-02

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)