binx io CT/NG Assay- Single-use Cartridge for the… recallZ-1626-2023 · Binx Health, Inc. · initiated Mar 29, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Binx Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Under Investigation by firm

What the company is doing

Binx issued Urgent Medical Device Recall Letter on 29 March 2023 via email. On 31 March 2023 a hard copy of the written Recall Notification and Response Form was sent via certified mail through the United States Postal Service. Letter states reason for recall, health risk and action to take: Discontinue use of the binx io CT/NG Assay lot listed above, and discard your inventory of this lot. " At the Clinic Director s discretion results may be reviewed. RESOLUTION: " binx health has removed this binx io CT/NG Assay lot from our inventory. We will provide alternate lots for all current and future replenishment orders or requests. Please share this information with your clinic staff and retain this notification as part of your clinic Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory or clinic, please provide them a copy of this letter. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. If you have any questions regarding this notice, please contact the binx Quality Assurance department by email at [email protected].

Recall details

Recall number: Z-1626-2023
Status: Open, Classified
Initiated by the company: Mar 29, 2023
Posted by the FDA: May 23, 2023
Recalling firm: Binx Health, Inc.
Quantity: 50 single-use cartridges
Product code: QEP
FDA submissions: K200533
Distribution: In the US state of PA

Product description

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

Code information (models, lots, serial numbers)

UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

binx io V1 (CT/NG)
Binx Health Limited · Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
1 recall1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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