BioFire Diagnostics recalls Respiratory Panel 2.1 (RP2.1) due to temperature excursions during shipping delays that could reduce test performance. Affected units may need retesting or replacement.
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 Respiratory Panel 2.1 (RP2.1) IVD test kits because shipping delays caused them to be stored outside the required temperature range. This could reduce the accuracy of respiratory tests. The recall does not require immediate action but may need retesting or replacement if the product was exposed to improper temperatures.
The test kits may have been stored outside the required temperature range due to shipping delays. This temperature excursion could reduce the accuracy of respiratory tests, potentially leading to less reliable results.
Healthcare facilities and labs that use BioFire Respiratory Panel 2.1 (RP2.1) kits for respiratory testing. Those who have the product and were exposed to improper temperatures during shipping are most at risk.
Check for the product name 'BioFire Respiratory Panel 2.1 (RP2.1)' with part number 423742. The recall applies to units shipped with lot number 1551622.
Review shipping records to determine if the product was exposed to improper temperatures during shipping delays.
If the product was exposed to improper temperatures, retest using a new kit to ensure accurate results.
The recall is due to temperature excursions during shipping delays that could reduce test performance.
No immediate action is required. The recall does not mandate stopping use but may require retesting if the product was exposed to improper temperatures.
Look for the product name 'BioFire Respiratory Panel 2.1 (RP2.1)' with part number 423742 and lot number 1551622.
We’ve drafted a message you can send BioFire Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1252-2023 — BioFire Diagnostics BioFire Diagnostics Hello, I own a BioFire Diagnostics that is covered by recall Z-1252-2023 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.
