Home / Recalls / Binx Health, Inc. / Z-1626-2023

Z-1626-2023 Class II Ongoing

Recalled by Binx Health, Inc. — Cambridge, MA

Recall Details

Product Type: Devices
Report Date: May 31, 2023
Initiation Date: March 29, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50 single-use cartridges

Product Description

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 Pattern

In the US state of PA

Code Information

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