Medical device recalls Moderate risk

Binx Health, Inc. recalls binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrho…

Recall date
March 29, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1626-2023
FDA classification
Class II
Brand / firm
Binx Health, Inc.
Sold / distributed
In the US state of PA

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Binx Health, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Binx Health, Inc.