Recall Z-0710-2022 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular, Inc.
Alinity m Integrated Reaction Units (IRU)
| Date | Feb 11, 2022 |
| Status | Terminated |
| Reason | There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. |
| Root cause | Under Investigation by firm |
| Action | On February 11, 2022, Abbott Molecular issued a Product Recall letter to all customers who received Integrated Reaction Unit (IRU) List Number 09N26-010 Lot Numbers 766233, 770433, 771200, 771201, and 773642 used with the Alinity m System. Consignees must complete and return the included customer reply form. Customers are instructed to follow the Necessary Actions outlined in the Customer Letter: Discontinue use of and discard all remaining inventory of IRU Lots 766233, 770433, 771200, 771201, and 773642. To coordinate replacement, contact your local Molecular Diagnostics at Abbott representa |
| Quantity | 3063 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.