Abbott Molecular, Inc. Recall 89603
Description: Alinity m Integrated Reaction Units (IRU)
Abbott Molecular, Inc. Recall 89603 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0710-2022 |
| Event ID | 89603 |
| Event Description | Alinity m Integrated Reaction Units (IRU) |
| Product Type | Devices |
| 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 |
| Recall Reason | There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. |
| Device Classification | 20220309 |
| Device 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 |
| Center Classification Date | 20220302 |
| Recall Initiation Date | 20220211 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | Letter |
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