SAM #154d05fd88e74af5b713fe6aa4b0ad37

FDA Sole Source Preventive Maintenance & Calibration for bioMérieux VITEK Instruments

The FDA Office of Regulatory Testing and Surveillance (ORTS) is seeking annual preventive maintenance and calibration services for proprietary bioMérieux VITEK instruments at seven FDA Human and Animal Food Laboratories nationwide. - Sole source contract intended for bioMérieux, Inc., the OEM of VITEK instruments - Services required for specific VITEK models: C 0015, C 0030, C 0060, MS PLUS, APS ONE, MYLA, and PREVI COLOR V2 - Quantities include: 1x C 0015, 1x C 0030, 7x C 0060, 2x MS PLUS, 1x APS ONE, 2x MYLA, 1x PREVI COLOR V2 - All maintenance and calibration must be performed by OEM-certified technicians using OEM parts - Compliance with ISO 17025 standards is mandatory - Vendors must demonstrate OEM authorization for servicing TEMPO and Media Prep systems - Contract period: 12-month base year plus four 12-month option years (up to 5 years total) - Services delivered at FDA Human and Animal Food Laboratories in Arkansas, Colorado, New York, California (Irvine and Alameda), Washington, and Georgia - Contracting office located in Rockville, MD - Only bioMérieux, Inc. is specified as the OEM; no other manufacturers are mentioned - Estimated contract value likely ranges from $250,000 to $750,000 over five years, based on typical service contracts for specialized laboratory equipment - Potential competitors are limited due to proprietary requirements, but companies like Thermo Fisher Scientific and Beckman Coulter may offer similar instrument maintenance for their own platforms - Competing products could include Thermo Fisher's MicroScan, Beckman Coulter's Microbiology systems, and Siemens' microbiology analyzers, though only bioMérieux VITEK instruments are specified

Description

The Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) intends to award a sole source contract to bioMérieux, Inc. (100 Rodolphe Street, Durham, NC 27712) for annual preventive maintenance (PM) and calibration of VITEK Instruments.

Services shall be performed at the following ORTS Laboratories:

Arkansas Human and Animal Food Laboratory (ARHAFL)- Jefferson, AR 72079-9502 Denver Human and Animal Food Laboratory (DENHAFL) -Denver, CO 80225-0087 New York Human and Animal Food Laboratory (NYHAFL) -Jamaica, NY 11433-1034 Irvine Human and Animal Food Laboratory (IRVHAFL)- Irvine, CA 92612-2506 Seattle Human and Animal Food Laboratory (SEAHAFL)- Bothell, WA 98021-4421 San Francisco Human and Animal Food Laboratory (SANHAFL)- Alameda, CA 94502 Atlanta Human and Animal Food Laboratory (ATLHAFL)- Atlanta, GA 30309

The contract will consist of a 12-month base period and four (4) 12-month option years. All services must be performed in accordance with ISO 17025 standards and by Original Equipment Manufacturer (OEM) certified technicians using only OEM parts.

This notice of intent is not a Request for Quote (RFQ). However, responsible sources may submit a capability statement demonstrating their status as an OEM-authorized dealer, distributor, or reseller. 

Submissions must include:

Company Name, Address, CAGE Code, and UEI. Evidence of OEM Authorization to service TEMPO and Media Prep systems. Confirmation of ability to provide OEM-certified technicians and parts. 

Responses to this notice must be sent via email to: Nina.Montgomery@fda.hhs.gov.

This notice will close on April 13, 2026 at 10am EST.

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