FDA (Devices) recall action 91647
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.