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Binx Health, Inc. recalls binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoe
Recalled May 31, 2023 · FDA recall Z-1626-2023 · Binx Health
Hazard
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 · FDA Class II
Units
50 single-use cartridges
Sold at
In the US state of PA
Description
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
Product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Manufacturer(s)
Binx Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →