Recall Z-1251-2023— BioFire Diagnostics, LLC

Name: FDA recall Z-1251-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-01

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-02-01. It names one FDA 510(k) clearance: K193519. Product: In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147. Reason: 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..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-02-01
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K193519 — BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC·cleared 2020-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.