Binx Health, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1626-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 29, 2023

Date Posted: May 31, 2023

Recall Number: Z-1626-2023

Event ID: 92143

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

Status: Ongoing

Product Quantity: 50 single-use cartridges

Code Information:

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

Distribution Pattern:

In the US state of PA

Voluntary or Mandated:

Voluntary: Firm initiated