---
title: "binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Ch... — FDA record Z-1626-2023 | Is It on Recall"
description: "May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce eit"
url: https://isitonrecall.com/recall/fda-device-z-1626-2023-binx-io-ct-ng-assay-single-use-cartridge-for-the-qualitative-detection-of-chlamydia-trachomatis-and/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorr... — FDA record Z-1626-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
- **Reason**: 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
- **Classification**: Class II
- **Recalling firm**: Binx Health, Inc.
- **Quantity**: 50 single-use cartridges
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1626-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1626-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

In the US state of PA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)

## Dates in the source

- **Report date**: May 31, 2023
- **Recall initiation date**: Mar 29, 2023
- **Center classification date**: May 23, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1626-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Binx Health, Inc. records](https://isitonrecall.com/brand/binx-health-inc/)