Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Summary
The FDA issued a Class II for Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. by Abbott Diagnostics Technologies AS. Reason: Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays.
Details
Source
Device Recall
External ID
Z-2736-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Lot/Code Info: Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
Quantity Affected: 5 analyzers
Reason for Recall
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
Distribution
US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-17
Company
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 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Diagnostics Technologies AS has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 Diagnostics Technologies AS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Diagnostics Technologies AS have FDA actions?
Abbott Diagnostics Technologies AS has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2736-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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