Z-2683-2024Class II

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Name: Z-2683-2024 BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Creator: BioFire Diagnostics, LLC
Published: 2024-06-10
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2024-06-10 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 on 2024-06-10. FDA classified it as Class II and gives the reason as "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". 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-2683-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-10
Posted: 2024-08-16
Recalling firm: BioFire Diagnostics, LLC
Product: BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Product code: QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected] 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 [email protected]. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.
Quantity in commerce: 24 Kits
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.
Product codes and lots: UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2683-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2682-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16
Z-2683-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16

Product code QDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)