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
#BarcodesProduct as published
120884999047864766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010
220884999047864770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010
320884999047864771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010
420884999047864771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010
520884999047864773642 / (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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 14, 2023 · Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.