Class II — Binx Health, Inc.
| Recalling firm | binx health, LTD. |
|---|---|
| Registered facility | BINX HEALTH, LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 50 single-use cartridges |
| Distribution | In the US state of PA |
| Initiated | 2023-03-29 |
| Classified | 2023-05-23 |
| Recall number | Z-1626-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Binx Health, Inc. (Z-1626-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92143/
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