Facility

Longhorn Vaccines and Diagnostics LLC

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011818318
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	7272 Wisconsin Avenue Bethesda, MD, US 20814
Registration status	Active · expires 2026
Parent company	Longhorn Vaccines and Diagnostics LLC (owner-operator 10077988)
Brand names	PrimeStore MTM

Activity by year

Recalls (1)
Inspections (1)
Warning letters (1)

Devices registered here (1)

Microbial Nucleic Acid Storage And Stabilization Device
Product code QBD (opens in a new tab) · Class II · Microbiology · 21 CFR 866.2950

Recalls & enforcement

Class IIOngoing2020-06-03
The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in…

FDA inspections (1)

OAI2025-10-30
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2026-02-27
Warning Letter (opens in a new tab) · Bethesda Maryland

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Longhorn Vaccines and Diagnostics LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Longhorn Vaccines and Diagnostics LLC (FEI 3011818318) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011818318-longhorn-vaccines-and-diagnostics-llc/

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