Alinity m Integrated Reaction Units recall
Alinity m Integrated Reaction Units (IRU)
Why was Alinity m Integrated Reaction Units recalled?
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Alinity m Integrated Reaction Units (IRU)
- Recalling firm
- Abbott Molecular, Inc.
- 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.
- Recall date
- March 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)