Facility

MEDTOX Diagnostics, Inc.

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

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

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

FDA Establishment Identifier (FEI)	3011260354
Establishment type	Manufacture Medical Device
Location	6624 Owens Drive Pleasanton, CA, US 94588
Registration status	Active · expires 2026
Parent company	MEDTOX DIAGNOSTICS, INC. (owner-operator 1050155)
Brand names	Labcorp Comfort Draw

Activity by year

Recalls (1)

Devices registered here (1)

System, Blood Collection, Vacuum-Assisted, Manual
Product code KST (opens in a new tab) · Class I · Hematology · 21 CFR 864.9125

Recalls & enforcement

Class IITerminated2013-04-05
Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

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. “MEDTOX Diagnostics, Inc. (FEI 3011260354) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011260354-medtox-diagnostics-inc/

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