BIOFIRE FILMARRAY Pneumonia Panel plus recall
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Why was BIOFIRE FILMARRAY Pneumonia Panel plus 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
- Product
- BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 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.
- Recall date
- August 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)