Afinion 2 Analyzer recall
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Why was Afinion 2 Analyzer recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
- Product
- Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
- Recalling firm
- Abbott Diagnostics Technologies AS
- Quantity
- 5 analyzers
- Distribution
- US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
- Recall date
- September 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)