Facility

ZEUS SCIENTIFIC LLC

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

Key facts

3recalls · worst Class II

2inspections · worst VAI

—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)	2242436
Establishment type	Manufacture Medical Device
Location	200 EVANS WAY BRANCHBURG, NJ, US 08876
Registration status	Active · expires 2026
Parent company	ZEUS SCIENTIFIC LLC (owner-operator 2242436)

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Product code MXJ (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3305

Recalls & enforcement

Class IIOngoing2023-10-31
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
Class IITerminated2019-08-12
FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.
Class IITerminated2019-07-22
Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that ant…

FDA inspections (2)

NAI2020-08-31
No Action Indicated · Postmarket Assurance: Devices; Project Evaluation: Devices
VAI2016-02-19
Voluntary Action Indicated · Bioresearch Monitoring · 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.

All facilities operated by ZEUS 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. “ZEUS SCIENTIFIC LLC (FEI 2242436) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2242436-zeus-scientific-llc/

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