Facility

BINX HEALTH, LTD.

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

Key facts

1recalls · 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)	3017907743
Establishment type	Manufacture Medical Device
Location	Whitehorse Business Park Trowbridge Wiltshire, GB BA14 OXG
Registration status	Active · expires 2026
Parent company	binx health, LTD. (owner-operator 10079710)
Brand names	binx io CT/NG Assay and binx io CT/NG System

Activity by year

Recalls (1)

Devices registered here (4)

Instrumentation For Clinical Multiplex Test Systems
Product code NSU (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.2570
Dna Probe, Nucleic Acid Amplification, Chlamydia
Product code MKZ (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3120
Dna-Reagents, Neisseria
Product code LSL (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3390
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Product code QEP (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3393

Recalls & enforcement

Class IIOngoing2023-03-29
May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results

All facilities operated by binx health, LTD.

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. “BINX HEALTH, LTD. (FEI 3017907743) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017907743-binx-health-ltd/

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