Z-0710-2022 Class II Terminated
FDA device recall Z-0710-2022 was initiated by Abbott Molecular, Inc. on February 11, 2022 and is designated Class II. Reason for recall: There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. The recall status is terminated (terminated April 14, 2023). Affected quantity: 3063 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- February 11, 2022
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3063 kits
Product Description
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 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.
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