Facility

IRVINE SCIENTIFIC LLC

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

Key facts

3recalls · 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)	3036495174
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	1830 E Warner Ave Santa Ana, CA, US 92705
Registration status	Active · expires 2026
Parent company	IRVINE SCIENTIFIC LLC (owner-operator 10092955)
Brand names	Continuous Single Culture®NX Complete (CSCMNXC)

Activity by year

Recalls (3)

Devices registered here (1)

Media, Reproductive
Product code MQL (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.6180

Recalls & enforcement

Class IIOngoing2023-11-02
The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Class IIOngoing2023-01-16
Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Class IIOngoing2021-09-08
Due to a component in kit being labeled with the incorrect Expiration Date

All facilities operated by IRVINE SCIENTIFIC 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. “IRVINE SCIENTIFIC LLC (FEI 3036495174) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3036495174-irvine-scientific-llc/

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