Qvella Corporation recalls The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating…
Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to downstream applications.
Read the official notice →- Date
- 2022-12-14
- Country
- United States
- Brand
- Qvella Corporation
- Product
- The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating…
- Classification
- Class II
- Units
- US: CA, NY, AL, UT
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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