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
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