Notice of Intent to Sole Source- BioMerieux

The Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) has issued a Notice of Intent to award a sole source contract to bioMerieux, Inc. for annual preventive maintenance and calibration services on VITEK laboratory instruments. The notice was posted on April 7, 2026, by the Department of Health and Human Services FDA Office of Acquisition and Grant Services. The contract will support seven ORTS laboratories located across Arkansas, Colorado, New York, California, Washington, and Georgia. The sole source justification is based on the proprietary nature of bioMerieux VITEK instruments, which require specialized expertise and OEM-authorized servicing to maintain warranty coverage and ISO 17025 accreditation compliance. This notice provides an opportunity for responsible sources to demonstrate their qualifications before the anticipated sole source award is finalized.

The primary objective of this procurement is to ensure continued operational reliability and regulatory compliance of critical laboratory diagnostic equipment through manufacturer-authorized maintenance and calibration services. The contract will consist of a 12-month base period followed by four optional 12-month renewal years, with all services required to meet ISO 17025 standards and be performed by OEM-certified technicians using only original equipment manufacturer parts. Interested parties must submit capability statements by April 13, 2026, at 10:00 AM EST demonstrating their status as OEM-authorized dealers, distributors, or resellers, and must include company name, address, CAGE Code, UEI, evidence of OEM authorization to service TEMPO and Media Prep systems, and confirmation of ability to provide OEM-certified technicians and parts. Submissions should be sent via email to Nina.Montgomery@fda.hhs.gov. The government reserves the right to determine whether to compete this requirement based on the responses received, making this a critical deadline for any qualified vendors seeking consideration beyond the current sole source intent.