FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

FDA device recall Z-1518-2025 · posted 2025-04-04 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

Action taken

On February 28, 2025, Biomerieux issued an "Urgent Field Safety Notice" Recall notification to affected consignees via email. The notice described the product, problem and actions to be taken. Biomerieux asked consignees to take the following actions: " Immediately examine your inventory for the lot identified in this field safety notice. " Discontinue use and discard any remaining product from this lot in your possession. bioMrieux will replace the product at no charge in accordance with our standard limited warranty. " Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. " If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative or call customer service department at 1-800-736-6354.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

QDS

Quantity affected

29 kits

Distribution

OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel

Date initiated

2025-02-27

Date posted

2025-04-04

Location

Salt Lake City, UT

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