Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Read the official notice →- Date
- 2021-11-10
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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