Facility

BIO-RAD LABORATORIES, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3002701146
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	14620 NE North Woodinville Way Woodinville, WA, US 98072
Registration status	Active · expires 2026
Parent company	BIO-RAD LABORATORIES, INC. (owner-operator 3022521)
Brand names	BioPlex 2200 MMRV IgG

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (4)

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Product code OPL (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3510
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Product code LJB (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3520
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Product code LJY (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3380
Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Product code LFY (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3900

Recalls & enforcement

Class IIOngoing2025-05-30
Due to a risk of false positive results that could lead to unnecessary medical treatment.

FDA inspections (2)

NAI2023-08-03
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-05-26
No Action Indicated · Compliance: Devices

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.

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. “BIO-RAD LABORATORIES, INC. (FEI 3002701146) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002701146-bio-rad-laboratories-inc/

Not open yet

Alerts for BIO-RAD LABORATORIES, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.