Qvella recalls FAST System and FAST PBC Prep Cartridge due to outdated user instructions for blood culture sample preparation. The recall corrects manual references to downstream applications to ensure safe use.
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.
Qvella is recalling its FAST System and FAST PBC Prep Cartridge for blood culture sample preparation. The recall involves correcting outdated instructions in the user manual to remove references to downstream applications that could lead to improper use.
The device exceeds the limitations of a Class I 510(k)-exempt device, meaning the original instructions were not appropriate for the intended use. The hazard involves outdated references to downstream applications that could lead to improper use if followed without correction.
Users of the FAST System and FAST PBC Prep Cartridge for blood culture sample preparation are affected. Laboratory professionals handling blood cultures are most at risk due to potential misuse of outdated instructions.
The FAST System and FAST PBC Prep Cartridge are used for isolating bacterial cells from blood cultures. Check for the product names and model numbers listed in the recall notice.
Check the user manual for corrected instructions that remove references to downstream applications.
The recall corrects outdated user instructions for blood culture sample preparation to ensure safe use, as the device exceeds the limitations of a Class I 510(k)-exempt device.
No, the recall does not require stopping use but involves updating the user manual to remove references to downstream applications.
Review the updated user manual for corrected instructions that remove references to downstream applications.
We’ve drafted a message you can send Qvella to request your refund or repair — edit it as you like.
Subject: Recall Z-0425-2023 — Qvella Qvella Hello, I own a Qvella that is covered by recall Z-0425-2023 from Qvella. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
