Recall Z-2245-2021

Reason for recall

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

FDA-determined cause: Process control

Action taken

On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 1) Immediately examine their inventory for product identified in this recall, 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Complete the accompanying Field Action Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to the Recalling Firm so that it may acknowledge their receipt of this notification. 4) If they may have further distributed the affected product, identify any recipients and notify them at once of this product recall. For product replacement, as well as any other questions or concerns, contact customer support department at Support@biofiredx.com or via telephone at 1-800-735-6544 and selecting option 5 for Product Technical Support.