Facility

Princeton BioMeditech Corp.

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

Key facts

2recalls · 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)	3026478115
Establishment type	Manufacture Medical Device
Location	85 Orchard Rd Skillman, NJ, US 08558
Registration status	Active · expires 2026
Parent company	PRINCETON BIOMEDITECH CORP. (owner-operator 2246703)
Brand names	AccuSign TCA; Status DS TCA

Activity by year

Recalls (2)

Devices registered here (3)

Radioimmunoassay, Tricyclic Antidepressant Drugs
Product code LFG (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3910
High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
Product code LFI (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3910
U.V. Spectrometry, Tricyclic Antidepressant Drugs
Product code LFH (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3910

Recalls & enforcement

Class IIOngoing2024-08-23
This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced f…
Class IITerminated2012-03-09
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

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. “Princeton BioMeditech Corp. (FEI 3026478115) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3026478115-princeton-biomeditech-corp/

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