Abbott Molecular, Inc. Alinity m Integrated Reaction Units (IRU) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

Recommended Action

Per FDA guidance

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.