BioFire Diagnostics, LLC: In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

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: 2 kits Lot/code info: Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022

UPC codes

0815381020338

Source

Official record: FDA (Device enforcement) ↗

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