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FDA (Device enforcement)Recalled 2024-06-10class ii

BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

Hazard

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 from the source

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. 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. Quantity: 58 Lot/code info: UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024

UPC codes

00815381020178

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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