BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Reported: August 28, 2024 Initiated: June 10, 2024 #Z-2682-2024
Product Description
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
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.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 58
- 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.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144. Recalled by BioFire Diagnostics, LLC. Units affected: 58.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2682-2024.
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