Summary
The FDA issued a Class II for Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 by Abbott Molecular, Inc.. Reason: Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits..
Details
Source
Device Recall
External ID
Z-0740-2023
Action Date
2022-12-28
Status
Ongoing
Category
device
Product Description
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Lot/Code Info: Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;
Quantity Affected: 12116 kits
Reason for Recall
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-22
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 404 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-0740-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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