Reported Mar 9, 2022 · Terminated
Alinity m Integrated Reaction Units (IRU)
Abbott Molecular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Molecular, Inc. · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315
Is this the product you have?
- Alinity m Integrated Reaction Units (IRU)
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 20884999047864766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2 20884999047864770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010 3 20884999047864771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010 4 20884999047864771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010 5 20884999047864773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010 - Amount recalled
- 3063 kits
Where it was sold
Why it was recalled
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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