BioFire Diagnostics recalls BCID2 IVD Panel due to temperature excursions during shipping delays that may reduce performance. Affected units include specific lot numbers and model.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
BioFire Diagnostics is recalling its BCID:2 IVD Panel because shipping delays caused temperature issues that might make the panel less effective. This could affect test accuracy if the panel is stored outside the required temperature range.
The panel may become less effective if stored outside the required temperature range due to shipping delays. This could lead to reduced test accuracy but does not pose a direct safety risk to users.
Healthcare facilities using the BioFire BCID2 Panel for diagnostic testing are most likely affected. The risk is low as the issue stems from shipping delays and not immediate harm.
Check for the product name 'BioFire BCID2 Panel' with part number RFIT-ASY-0147. The pouch lot number 1766022 identifies affected units.
Verify the part number RFIT-ASY-0147 and pouch lot number 1766022 to confirm if your panel is affected.
The recall is due to temperature excursions during shipping delays that may reduce panel performance.
Check for part number RFIT-ASY-0147 and pouch lot number 1766022 on the panel packaging.
No, the recall does not require immediate discontinuation; affected units should be checked for proper temperature storage.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1251-2023 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1251-2023 from BioFire Diagnostics. 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.
