Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

binx io CT/NG Assay- Single-use Cartridge for the qualitative detection Recalled by Binx Health, Inc. Due to May not meet the declared performance characteristics for...

Date: March 29, 2023
Company: Binx Health, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Binx Health, Inc. directly.

Affected Products

binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101

Quantity: 50 single-use cartridges

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: PA

Affected (1 state)Not affected

About Binx Health, Inc.

Binx Health, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report