FilmArray Pneumonia Panel Plus (Pneumoplus), REF:… recallZ-0993-2024 · BioFire Diagnostics, LLC · initiated Dec 14, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Their is a potential for false positive results when using Pneumonia panel.

FDA root cause category: Under Investigation by firm

What the company is doing

On December 14, 2023, Biomerieux, issued a "Urgent Medical Recall" to affected consignees via: FedEx . Biomerieux asked consignees to take the following actions: 1. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. 2. Use another method to confirm positive results for seasonal Coronavirus from the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus prior to reporting the result (e.g., consider results from testing a nasopharyngeal swab with a different BIOFIRE respiratory panel such as the BIOFIRE Respiratory Panel 2.1). Alternatively, the BIOFIRE Pneumonia Panel or BIOFIRE Pneumonia Panel plus seasonal Coronavirus positive result should not be reported. 3. Complete the Acknowledgement Form in Attachment A (on the following page) and return it to bioMrieux to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this urgent product correction notice does not impact your facility.

Recall details

Recall number: Z-0993-2024
Status: Open, Classified
Initiated by the company: Dec 14, 2023
Posted by the FDA: Feb 6, 2024
Recalling firm: BioFire Diagnostics, LLC
Quantity: 214,080 pouches
Product code: QDS
FDA submissions: K181324
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Argentina, Bolivia, Brazil, Chili, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Hong Kong, Honduras, Japan, South Korea, Mexico, Nicaragua, Panama, Peru, Philippines, Paraguay, Singapore, El Salvador, Thailand, Taiwan, Uruguay, Venezuela.

Product description

FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

Code information (models, lots, serial numbers)

UDI: 00815381020314/ All unexpired lots

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

FilmArray® Pneumonia Panel plus (Pneumoplus) RFIT-ASY-0143
Biofire Diagnostics, LLC · Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
3 recalls3 deaths4 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 93592).

Z-0994-2024 · Open, Classified
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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