Device product

Alinity m Integrated Reaction Units (IRU)

Z-0710-2022

February 11, 2022

Class II

Product summary

Firm: Abbott Molecular, Inc.
Event: Event 89603
Status: Terminated
Classification: Class II
Quantity: 3063 kits
Official record key: device-enforcement:Z-0710-2022

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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