Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-2683-2024 · Posted 2024-08-16

Recalling FirmBioFire Diagnostics, LLC
Recall StatusOpen, Classified
Product CodeQDS
Date Initiated2024-06-10
Product Quantity24 Kits

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.

Firm Action

On 6/10/24, field safety notices were sent to laboratory managers who were informed of the following: Discontinue use and discard any remaining product in your possession. If you have further distributed this product, please identify any recipients, and notify them at once. Complete and return the Acknowledgement of Receipt Form and return via email to [email protected] If you have questions, please contact your firm's local US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑