# FDA recall Z-1626-2023

> **Binx Health, Inc.** · Class II · device recall initiated 2023-03-29.

## Product

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

## Reason for recall

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

## Distribution

In the US state of PA

## Key facts

- **Recall number:** Z-1626-2023
- **Recalling firm:** Binx Health, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-29
- **Report date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1626-2023

## Citation

> AI Analytics. FDA recall Z-1626-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1626-2023. Source: US FDA. Licensed CC0.

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