In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

FDA device recall Z-1251-2023 · posted 2023-03-15 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

Action taken

On 02/01/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email to customers informing them of a "Temperature Out of Range" issue with multiple products, as a result from Hurricane Ian (10/2022) Customers are Instructed to: Immediately examine their inventory for product identified in this recall. 1. Discontinue use and discard any remaining product in their possession that is subject to this recall. bioMerieux will replace the product at no charge in accordance with BIOFIRE s standard limited warranty. 2. Complete the accompanying Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to bioMerieux so that bioMerieux may acknowledge their receipt of this notification. 3. If customers have further distributed this product, please identify any recipients, and notify them at once of this product recall. For questions or concerns, contact customer support department at biofiresupport@biomerieux.com or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support

Root cause

Environmental control

Status

Open, Classified

Product code

PEN

Quantity affected

2 kits

Distribution

U.S. Nationwide distribution in the states of FL and GA.

Date initiated

2023-02-01

Date posted

2023-03-15

Location

Salt Lake City, UT

Related 510(k) clearances