FDA recall Z-0710-2022

Abbott Molecular, Inc. · Class II · device

Product

Alinity m Integrated Reaction Units (IRU)

Reason for recall

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

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.

Key facts

Status
Terminated
Initiation date
2022-02-11
Report date
2022-03-09
Termination date
2023-04-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0710-2022