BioFire Diagnostics, LLC: In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: U.S. Nationwide distribution in the states of FL and GA. Quantity: 8 kits Lot/code info: Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622

UPC codes

00815381020482

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.