Abbott Diagnostics Technologies AS recalls Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
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.
Read the official notice →- Date
- 2024-09-04
- Country
- United States
- Brand
- Abbott Diagnostics Technologies AS
- Product
- Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AZ, IN, MA, MN, and OH.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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