Z-0994-2024Class II

FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

Name: Z-0994-2024 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Creator: BioFire Diagnostics, LLC
Published: 2023-12-14
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-12-14 / Open, Classified

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) on 2023-12-14. FDA classified it as Class II and gives the reason as "Their is a potential for false positive results when using Pneumonia panel". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0994-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-14
Posted: 2024-02-06
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Product code: QBH Lower Respiratory Microbial Nucleic Acid Detection System
Reason for recall: Their is a potential for false positive results when using Pneumonia panel.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 274,290 units
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 codes and lots: UDI: 00815381020178/ All unexpired lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0994-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0993-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06
Z-0994-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06

Product code QBH

K180966Class IIFilmArray Pneumonia PanelBiofire Diagnostics, LLC / cleared 2018-11-09

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)