BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

FDA device recall Z-2682-2024 · posted 2024-08-16 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

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.

Action taken

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 usfieldactions@biomerieux.com 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 BioFireSupport@biomerieux.com. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

QDS

Quantity affected

58

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.

Date initiated

2024-06-10

Date posted

2024-08-16

Location

Salt Lake City, UT