BioFire Diagnostics, LLC: Medical Device Recall in 2023 - (Recall #: Z-1392-2023)

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:

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Product Classification:

Class II

Date Initiated: March 8, 2023

Date Posted: April 26, 2023

Recall Number: Z-1392-2023

Event ID: 91892

Reason for Recall:

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

Status: Ongoing

Product Quantity: 900 pouches (30 kits)

Code Information:

Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

Distribution Pattern:

US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.

Voluntary or Mandated:

Voluntary: Firm initiated