Summary
The FDA issued a Class II for Alinity m Integrated Reaction Units (IRU) by Abbott Molecular, Inc.. Reason: There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot..
Details
Source
Device Recall
External ID
Z-0710-2022
Action Date
2022-03-09
Status
Terminated
Category
device
Product Description
Alinity m Integrated Reaction Units (IRU)
Lot/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
Quantity Affected: 3063 kits
Reason for Recall
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-11
Company
Des Plaines, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Molecular, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Molecular, Inc. have FDA actions?
Abbott Molecular, Inc. has 39 FDA actions in our database, including 30 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0710-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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