FDA recall Z-2683-2024

Product

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Reason for recall

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

Distribution

Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.

Key facts

Status

Ongoing

Initiation date

2024-06-10

Report date

2024-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2683-2024