Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0710-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Alinity m Integrated Reaction Units (IRU)

Product Classification:

Class II

Date Initiated: February 11, 2022

Date Posted: March 9, 2022

Recall Number: Z-0710-2022

Event ID: 89603

Reason for Recall:

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

Status: Terminated

Product Quantity: 3063 kits

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated