Z-1518-2025Class II

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

Name: Z-1518-2025 FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Creator: BioFire Diagnostics, LLC
Published: 2025-02-27
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2025-02-27 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 on 2025-02-27. FDA classified it as Class II and gives the reason as "Increased risk of control failures and false negative test results with multiplexed nucleic acid test". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1518-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-27
Posted: 2025-04-04
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Product code: QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Reason for recall: Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 29 kits
Distribution: OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Product codes and lots: UDI: 00815381020314/Lot# 0979424

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1518-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04

Product code QDS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)