Alinity m Integrated Reaction Units (IRU)
Check against the official notice below — it lists the full affected range.
Abbott Molecular, Inc. is recalling 3,063 kits of Alinity m Integrated Reaction Units (IRU) distributed nationwide across 22 states. The recall addresses a potential safety issue where Reaction Vessels (RVs) may detach from the RV cap during transport by the pipettor robot. The affected product is List Number 09N26-010, and the recall involves five specific lot numbers: 766233, 770433, 771200, 771201, and 773642.
The recall record does not specify any remedy or instructions for consumers regarding what action should be taken with the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
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. Quantity: 3063 kits Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.