Facility

BIOCARE MEDICAL, LLC

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

Key facts

5recalls · worst Class II

1inspections · 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)	3004140393
Establishment type	Manufacture Device in the United States for Export Only
Location	60 Berry Drive Pacheco, CA, US 94553
Registration status	Active · expires 2026
Parent company	BIOCARE HOLDINGS, LLC (owner-operator 9058052)
Brand names	Epstein-Barr Virus (EBV)

Activity by year

Recalls (5)
Inspections (1)

Devices registered here (1)

Epstein-Barr Virus, Other
Product code LSE (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3235

Recalls & enforcement

Class IIOngoing2024-09-25
Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
Class IITerminated2021-02-25
Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This …
Class IITerminated2019-10-10
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosi…
Class IITerminated2018-04-24
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Class IITerminated2018-03-15
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.

FDA inspections (1)

NAI2016-01-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

All facilities operated by BIOCARE HOLDINGS, 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. “BIOCARE MEDICAL, LLC (FEI 3004140393) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004140393-biocare-medical-llc/

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