BioFire Diagnostics recalls FilmArray GI Panel (REF RFIT-ASY-011:1674322) due to temperature excursions during shipping that may reduce diagnostic performance. Affected units were sold with specific lot numbers.
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 FilmArray GI Panel diagnostic test kits because shipping delays caused them to be stored outside the required temperature range. This could reduce the test's accuracy. If you have this product, check the lot number on the pouch to see if it's affected.
The test kits may not work properly if stored outside the required temperature range during shipping. This happens because shipping delays caused the products to be exposed to temperatures that could reduce their performance.
Healthcare professionals using the FilmArray GI Panel for diagnostic testing are most likely affected. The recall targets specific lot numbers sold through BioFire's distribution channels.
Check the pouch for lot number 1674322. The product was sold with the reference number RFIT-ASY-0116 and UDI 00815381020109.
Look for lot number 1674322 on the pouch of the FilmArray GI Panel.
Shipping delays caused the products to be stored outside the required temperature specifications, which may reduce performance.
Check the pouch for lot number 1674322. The product was sold with reference number RFIT-ASY-0116 and UDI 00815381020109.
The recall does not require immediate action; check the lot number to see if it's affected.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1253-2023 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1253-2023 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.
