BioFire Diagnostics, LLC: Medical Device Recall in 2023 - (Recall #: Z-1252-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 1, 2023

Date Posted: March 22, 2023

Recall Number: Z-1252-2023

Event ID: 91647

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.

Status: Ongoing

Product Quantity: 8 kits

Code Information:

Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622

Distribution Pattern:

U.S. Nationwide distribution in the states of FL and GA.

Voluntary or Mandated:

Voluntary: Firm initiated