Sofie recalls Neuraceq Fluorbetaben injection due to potential contamination. This diagnostic imaging product may not be sterile, risking infection. Check your vial's batch number for affected units.
Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
Sofie has recalled Neuraceq Fluorbetaben injection solutions because tests showed the vials might not be sterile. This could lead to infections if used in medical procedures.
The injection solution failed sterility tests, meaning it could contain harmful bacteria. This poses a risk of infection during medical procedures, though the actual risk level is low due to the product's use in controlled medical settings.
Healthcare providers using this diagnostic imaging product for medical scans. Patients receiving the injection are at risk if the product is contaminated.
Check for the batch number FBBVA123082201 on the vial. The product was manufactured for life by Sofie in Dulles, VA and sold with NDC 54828-001-50.
Look for the batch number FBBVA123082201 on the vial to confirm if it's affected.
The product was recalled due to potential contamination risks, but it is not safe to use without checking the batch number.
Check the batch number on the vial; if it matches FBBVA123082201, contact Sofie for instructions.
The product was manufactured with batch number FBBVA123082201 and sold with NDC 54828-001-50; check these details.
We’ve drafted a message you can send Sofie to request your refund or repair — edit it as you like.
Subject: Recall D-1177-2023 — Sofie Sofie Hello, I own a Sofie that is covered by recall D-1177-2023 from Sofie. 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.
