FDAFDA · Food and drugs·Recall number Z-2736-2024
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Published September 4, 2024 · Recall initiated: June 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Diagnostics Technologies AS
- Distributor
- US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
- Lot
- Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Norway
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