BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 recallZ-2683-2024 · BioFire Diagnostics, LLC · initiated Jun 10, 2024
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
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2683-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 10, 2024
- Posted by the FDA
- Aug 16, 2024
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 24 Kits
- Product code
- QDS
- 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 description
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Code information (models, lots, serial numbers)
UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
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-0143Biofire Diagnostics, LLC · Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System3 recalls3 deaths4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94942).
- Z-2682-2024 · Open, ClassifiedBIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
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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