Drugs & medicalClass II

Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047

A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.

Read the official notice →
Date
2022-11-02
Country
United States
Brand
Luminex
Product
ARIES SARS-CoV-2 Assay, REF: 50-10047
Classification
Class II
Units
Distribution US nationwide, Indonesia, and Hong Kong.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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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