Luminex Corporation recalls ARIES SARS-CoV-2 Assay
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative…
Read the official notice →- Date
- 2022-08-24
- Country
- United States
- Brand
- Luminex
- Product
- ARIES SARS-CoV-2 Assay
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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