BioFire Diagnostics, LLC: Medical Device Recall in 2024 - (Recall #: Z-0993-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

Product Classification:

Class II

Date Initiated: December 14, 2023

Date Posted: February 14, 2024

Recall Number: Z-0993-2024

Event ID: 93592

Reason for Recall:

Their is a potential for false positive results when using Pneumonia panel.

Status: Ongoing

Product Quantity: 214,080 pouches

Code Information:

UDI: 00815381020314/ All unexpired lots

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated