Recall Z-1944-2021

Reason for recall

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

FDA-determined cause: Under Investigation by firm

Action taken

On 04/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via email informing its customers of an issue identified in the manufacturing process which might contribute to elevated rates of false positive/false negative results and control failures while using the pneumonia panel. Customer are instructed to: 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) Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. 4) If the affected products have been further distributed, customers are to identify any recipients and notify them at once of this product recall. 5) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to Recalling Firm so that it may acknowledge their receipt of this notification. For questions or concerns contact Customer Support Department at Support@biofiredx.com or via telephone 1-800-735-6544, option 5 for Product Technical Support.